Category: Circular

FDA Circular No. 2021-001-A || Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for Medical Device Based on the ASEAN Harmonized Technical Requirements”

Attachment:-> FDA-Circular-No.2021-001-A

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2021-001-A || Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for Medical Device Based on the ASEAN Harmonized Technical Requirements”

FDA Circular No. 2021-002 || Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAB Harmonized Technical Requirements”

Attachment:-> FDA-Circular-No.2021-002

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2021-002 || Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAB Harmonized Technical Requirements”

FDA Circular No. 2020-037 || Reissuance of the Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19

I. RATIONALE

Last 17 March 2020, the Food and Drug Administration issued FDA Circular No. 2020-007 entitled “Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19.”

Said Guidelines were issued to allow dispensation of drugs to Senior Citizens, Persons with Disability (PWD), and patients with chronic illness or those with immuno-compromised conditions who need to take prescription medicines and maintenance drugs with based in an electronic prescription issued by a licensed physician.

Through amendments, the effectivity of said Circular was extended until 31 December 2020 regardless of the level of the imposed quarantine restrictions due to COVID-19.

Considering that the COVID-19 Pandemic continues to threaten the health and safety of vulnerable individuals, it is imperative that the Guidelines implementing the use of electronic prescriptions be maintained to ensure continuous access of said individuals to prescription medicines and maintenance drugs.

Hence, the Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19 is hereby reissued.

II. OBJECTIVES

This Circular aims to achieve the following:

  1. Ensure access to prescription medicines and maintenance drugs for all individuals vulnerable to COVID-19 through the use of electronic means or electronic prescription;
  2. Ensure efficient and effective process for electronic prescription of drugs; and
  3. Provide guidelines on how to dispense prescription drugs based on the electronic prescription issued by licensed physician. 

III. SCOPE AND COVERAGE

This Circular shall apply to all individuals vulnerable to COVID-19 as defined under this Circular and to all licensed physicians authorized to prescribe drugs to the aforementioned individuals. The same Circular shall cover all Drugstore/Pharmacy/Botica and similar outlets, but shall not include prescription that requires PDEA S-2 license.

IV. DEFINITION OF TERMS AND ACRONYMS

  1. Dispensingrefers to the sum of processes performed by a pharmacist from reading, validating, and interpreting prescriptions; preparing; packaging; labeling; record keeping; dose calculations; and counseling or giving information, in relation to the sale or transfer of pharmaceutical products, with or without a prescription or medication order;
  1. Drugsis defined as:

a. articles recognized in official pharmacopeias and formularies, including official homeopathic pharmacopeias, or any documentary supplement to any of them, which are recognized and adopted by the FDA

b. articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals

c. articles (other than food) intended to affect the structure of any function of the body of humans or animals

d. articles intended for use as a component of any articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or accessories.

  1. Individuals Vulnerable to Covid-19 refers to all individuals, regardless of age and nationality, who are either Senior Citizens, Persons with Disability (PWD), with chronic illness or those with immuno-compromised conditions who need to take prescription medicines and maintenance drugs;
  1. Licensed Physician refers to all individuals licensed or authorized to practice medicine as defined by Republic Act No. 2382 or the Medical Act of 1959, as amended;
  1. Electronic Prescription refers to the optical electronic data (captured image in pdf, jpeg or other photo file format) issued by or made by a licensed physician which is generated, sent, received or stored through email and messaging applications (i.e. WhatsApp, Viber, Line, and Messenger among others). The said electronic document shall contain the medical prescription needed by the individuals vulnerable to COVID-19 and the electronic signature of the licensed physician;
  1. Pharmacistrefers to a health professional who has been registered and issued a valid Certificate of Registration (COR) and Professional Identification Card (PIC) by the PRC and the Professional Regulatory Board of Pharmacy;
  1. Drugstore/Pharmacy/Botica and similar outlets including hospital pharmacy and institutional pharmacy shall refer to drug establishment were registered drug, chemical products, dental, medicinal and household remedies are dispensed directly to the general public on a retail basis.

V. GUIDELINES

A. Issuance of Electronic Prescription by Licensed Physician

  1. All licensed physicians shall be authorized to issue electronic prescriptions pursuant to this Order by issuing it via email or any other alternative modes considered electronic document acceptable under the Electronic Commerce Act of 2000.
  1. The electronic prescription shall be deemed equivalent to a written prescription required under FDA Circular No. 2014-025.
  1. All licensed physician shall issue a separate electronic prescription for all Anti-biotic, Anti-infectives, and or Anti-viral preparations.
  1. All electronic prescriptions shall contain the name of the individual to whom the medicines or drugs are prescribed, the name of the medicines and/or drugs prescribed, the dosage and all other pertinent matters similarly contained in a written prescription.
  1. All electronic prescriptions shall contain a digital signature, name, license number, Professional Tax Receipt (PTR) [if applicable] of the licensed physician.
  1. All licensed physicians who made us of the electronic prescription shall keep records of all electronic prescriptions he/she issued pursuant to this Order.

B. Dispense of Medicines pursuant to an Electronic Prescription

  1. All Drugstore/Pharmacy/Botica and similar outlets shall recognize the validity and effectivity of the electronic prescription issued by the licensed physician. Prescription containing Anti-biotic, Anti-infectives, and or Anti-viral preparations shall only be valid for one (1) week after its issuance.
  1. All Drugstore/Pharmacy/Botica and similar outlets shall strictly dispense drugs as prescribed by the electronic prescription and the latter shall be deemed equivalent to a written prescription for all intents and purposes.
  1. All Drugstore/Pharmacy/Botica and similar outlets shall not require the actual presence of the individual vulnerable to COVID-19 before dispensing the needed drugs. A duly authorized representative may purchase the said drugs on behalf of the latter.

In the event that the patient is a Senior Citizen (SC) and/or Persons with Disability (PWD), the following should be presented together with the electronic prescription prior to the dispensing of the needed drugs:

  1. A letter of authorization duly signed by the concerned individual; and
  2. Identification card of the SC and/or PWD

 VI. REPEALING CLAUSE

In the event that any provision or part of this Circular is declared unauthorized or rendered invalid by any court of law, those provisions not affected by such declaration shall remain valid and effective.

VII. EFFECTIVITY

This Circular shall take effect immediately and shall be valid until 12 September 2021, regardless of the level of the imposed quarantine restrictions due to COVID-19.

Attachment:-> FDA Circular No.2020-037

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2020-037 || Reissuance of the Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19

FDA Circular No. 2020-028-A || EXTENSION OF THE EFFECTIVITY OF FDA CIRCULAR NO. 2020-028 ENTITLED “REISSUANCE OF THE GUIDELINES FOR THE REGISTRATION OF DRUG PRODUCTS UNDER EMERGENCY USE (DEU) FOR THE CORONAVIRUS DISEASE 2019 (COVID-19)”

In the interest of service and due to the continuing COVID-19 Pandemic, the effectivity of FDA Circular No. 2020-028 entitled “Reissuance of the Guidelines for the Registration of Drug Products Under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)” is hereby extended until 12 September 2021, regardless of the level of the imposed quarantine restrictions due to COVID-19.

For the information and guidance of the public.

Attachment:-> FDA Circular No.2020-028-A

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2020-028-A || EXTENSION OF THE EFFECTIVITY OF FDA CIRCULAR NO. 2020-028 ENTITLED “REISSUANCE OF THE GUIDELINES FOR THE REGISTRATION OF DRUG PRODUCTS UNDER EMERGENCY USE (DEU) FOR THE CORONAVIRUS DISEASE 2019 (COVID-19)”

FDA Circular No. 2020-022-A || EXTENSION OF THE EFFECTIVITY OF FDA CIRCULAR NO. 2020-022 ENTITLED “REISSUANCE OF THE GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCY”

In the interest of service and due to the continuing COVID-19 Pandemic, the effectivity of FDA Circular No. 2020-022 entitled “Reissuance of the Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, and Review and Monitoring of Donated Health Products Solely Intended to Address COVID-19 Public Health Emergency” is hereby extended until 12 September 2021.

For the information and guidance of the public.

Attachment:-> FDA Circular No.2020-022-A

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2020-022-A || EXTENSION OF THE EFFECTIVITY OF FDA CIRCULAR NO. 2020-022 ENTITLED “REISSUANCE OF THE GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCY”

FDA Circular No. 2020-036 || Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19

        I. BACKGROUND/ RATIONALE

Article II, Section 15 of the 1987 Constitution of the Republic of the Philippines mandates the State to protect and promote the health of the people and instill health consciousness among them. The State is further mandated under Article XIII, Section 11 of the Constitution to adopt an integrated and comprehensive approach to health development which shall endeavor to make essential goods, health and other social services available to all the people at affordable cost.

Under Republic Act No. 3720, or the “Food, Drug and Cosmetic Act,” as amended by Executive Order No. 175, s. 1987, and Republic Act No. 9711, or the “Food and Drug Administration Act of 2009,” the Food and Drug Administration (FDA) was created to establish and maintain a drug regulatory system to ensure the purity, safety, efficacy and quality of drugs and vaccines in the country. Section 21 of Republic Act No. 3720, as amended, provides that any new drug should have an authorization from the FDA based on an application containing full reports of investigations to show whether or not such drug is safe, efficacious and of good quality for use based on clinical studies, prior to manufacture, sale, importation, exportation, distribution or transfer thereof.

Pursuant to Proclamation Nos. 922 (s. 2020) and 1021 (s.2020), the Philippines was declared under a State of Public Health Emergency, and a State of Calamity due to the COVID-19 pandemic.

Subsequently, Republic Act No. 11494 or the “Bayanihan to Recover as One Act” was enacted authorizing the President to suppress the COVID-19 pandemic through the procurement of drugs and vaccines.

Considering that no registered drug and vaccine exist for COVID-19 in the Philippines, the President of the Republic of the Philippines issued Executive Order (EO) No. 121 entitled “Granting Authority to the Director General of the Food and Drug Administration to Issue Emergency Use Authorization (EUA) for COVID-19 Drugs and Vaccines, Prescribing Conditions therefore and for other Purposes.” Said issuance gave authority to the Director General to issue an EUA, and established the conditions under which said authorization may be issued.

The FDA is hereby introducing the process for the issuance of EUA to sustain and strengthen the national preparedness for the COVID-19 public health emergency. The principles of regulatory reliance and recognition are adopted to accelerate the evaluation and approval process for EUA to ensure immediate access to drug products and vaccines for COVID-19.

II. OBJECTIVES

This Circular aims to provide guidelines on the regulation of EUA for drugs and vaccines for COVID-19.

III. SCOPE AND APPLICATION

This Circular shall apply to the pharmaceutical industry and government entities such as the national procurer or health program implementors intending to apply for an EUA for drugs and vaccines for COVID-19, and shall pertain only to unregistered (anywhere in the world) drugs and vaccines for prevention, diagnosis and treatment of COVID-19 and granted an EUA by the National Regulatory Authority (NRA) of the country of origin or any other mature and established NRA as identified by FDA.

IV. DEFINITION OF TERMS

A. Emergency Use Authorization (EUA) – is an authorization issued for unregistered drugs and vaccines in a public health emergency. The EUA is not a Certificate of Product Registration (CPR) or a marketing authorization. The evaluation process of the product may be facilitated by reliance and recognition principles, but stricter conditions on the use and monitoring following authorization shall be imposed.

B. Drugs – as used in this issuance, refer to pharmaceutical products that pertain to chemical compounds or biological substances, other than food, intended for use in the treatment, prevention, or diagnosis of disease in humans or      animals, including the following:

1. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man,

2. Articles (other than food) intended to affect the structure or any function of the body of humans, and

3. Articles intended for use as a component of any articles specified in the foregoing clauses but do not include devices or their components, parts or accessories.

C. Recognition – shall refer to the acceptance of the regulatory decision of another trusted institution. It shall be based on evidence of conformity that the regulatory requirements of the reference regulatory authority are sufficient to meet the regulatory requirements of the relying authority.

D. Reliance – shall refer to the act whereby the NRA in one jurisdiction may take into account and give significant weight to assessments performed by another NRA or trusted institution, or to any other authoritative information in reaching its own decision.

V. GENERAL GUIDELINES

A. The EUA shall only be issued and remain valid under all of the following conditions provided herein.

B. The applicant shall submit requirements to support the application for EUA.

C. The Center for Drug Regulation and Research (CDRR) and an Expert Panel shall review the application and provide recommendations on the COVID-19 drug or vaccine being applied for an EUA.

D. The Director General shall act on the application by either issuing the EUA or a Letter of Disapproval (LOD).

E. A COVID-19 drug or vaccine with issued EUA shall be subject to post authorization surveillance. Pharmacovigilance obligations and post-authorization commitments shall be imposed on the holder of the EUA. The pharmacovigilance obligations and post-authorization commitments by the holder of the EUA shall also be shared with the national procurer and health program implementors.

A flowchart of the process for the issuance of the EUA for drugs and vaccines is provided in Annex “A” of this Circular.

VI. SPECIFIC GUIDELINES

A. Conditions for Issuance of the EUA

The EUA shall only be issued and remain valid only when all of the following circumstances are present:

  1. Based on the totality of evidence available, including data from adequate and well- known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose, or treat COVID-19;
  1. The known and potential benefits of the drug or vaccine, when used to diagnose, prevent, treat COVID-19, outweigh the known and potential risks of the drug or vaccine, if any; and
  1. There is no adequate, approved and available alternative to the product for diagnosing, preventing or treating COVID-19.

The last condition is deemed present when there exists no registered drug or vaccine in the country for diagnosing, preventing or treating COVID-19.

B .Filing of Application

All applications shall be filed with the FDA Action Center (FDAC).

C. Requirements

Applications for EUA for drugs and vaccines shall comply with the following documentary requirements which shall be in the English language.

  1. Cover letter requesting to issue an EUA with comprehensive discussions on the public health need for the product,
  2. Valid License to Operate (LTO) as Drug Importer, with copy of the exclusive distributorship agreement with the manufacturer of the drug or vaccine,
  3. Good Manufacturing Practice (GMP) Certificate or equivalent document issued by the national regulatory authority or other competent regulatory authority. For drugs or vaccines coming from non-PIC/S countries or non-WHO-Prequalified, the application must be supported by a Foreign current Good Manufacturing Practice (FcGMP) Certificate following Administrative Order No. 2013-0022 (see Annex “B” for list PIC/S Member Countries),
  4. List of Countries where the EUA is approved, with proof of approval for emergency use (or equivalent document) from the corresponding approving counterpart NRAs,
  5. Reports on actual use from the issuance of EUA of approving counterpart NRA to the application for EUA in the Philippine FDA;
  6. Complete assessment report including question and answer documents from the approving counterpart NRA,
  7. Clinical trial data and results with the inclusion of racial distribution showing Filipino/Asians/ Pacific Islanders,
  8. Currently available stability studies and list of ongoing studies,
  9. Risk Management Plan,
  10. Summary of Product Characteristics,
  11. Summary Lot Protocol,
  12. Product labeling with minimum information including name of vaccine, type of vaccine, method of administration, dose per vial, storage, batch or lot number, manufacturing and expiration dates (compliance with Administrative Order No. 2016-0008 or the Revised Rules and Regulations Governing the Generic Labelling Requirements of Drug Products for Human Use shall not be required), and instruction for usage— smart labelling is encouraged; and
  13. Proof of Payment (Official Receipt or Landbank Oncoll Payment Slip).

Should the above stated requirements be unavailable, a sufficient justification should be provided with an undertaking to submit the requirement when available.

The above stated requirements may be updated or supplemented by the FDA through circulars on the matter. Further, the FDA may require additional documents should it deem necessary for proper review of the drug or vaccine applied for EUA.

In all applications for EUA, a sworn assurance of sameness that the product including but not limited to the composition/ formulation, strength, manufacturing of finished product and active pharmaceutical ingredients, specifications, packaging, product information and others, at the time of the submission and after EUA, are the same in all respects as the product given the EUA by the approving counterpart NRA. Also, the application should be accompanied by an undertaking by the manufacturer to complete the development of the drug and vaccine applied for an EUA.

D. Pre-assessment

The Office of the Director General (ODG) shall determine the completeness of the submission for application. Thereafter, the application shall be referred to the Expert Panel and CDRR for a simultaneous review of the application.

E. Review and Recommendation

CDRR shall review the quality of the drug or vaccine applied for an EUA based from the requirements submitted.

In addition to the review of the CDRR, the Director General shall also consult an Expert Panel which shall review the safety and efficacy of the product applied for EUA. The Expert Panel shall come up with its recommendations to the Director General on the action on the application for EUA.

The Expert Panel shall be composed of at least three (3) experts on drug and vaccine development or related fields such as immunology, infectious disease, pharmacology, public health, toxicology and others.

The review of the expert panel shall identify whether (a) based on the totality of evidence available, including data from adequate and well- known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose, or treat COVID-19, and (b) the known and potential benefits of the drug or vaccine, when used to diagnose, prevent, treat COVID-19, outweigh the known and potential risks of the drug or vaccine, if any.

The identity and recommendations of the Expert Panel shall be strictly confidential.

The recommendations of CDRR and the Expert Panel are for the consideration of the Director General.

F. Decision

1. Approval of the application for EUA

The FDA may rely on and/or recognize EUAs of mature and established NRAs as enumerated in Annex “C” of this Circular. The FDA may also issue circulars at any point to include other regulatory agencies that it deems mature and established.

Only the Director General shall approve the application for EUA. The Director General shall issue the EUA after having been satisfied that all of the conditions as provided in this issuance exist.

The approval may include one or more special conditions for use. These can include post-authorization safety and effectiveness reporting requirements, limitations, restrictions on advertising and promotion, and other special conditions.

2. Disapproval

The following shall be considered as basis for disapproval of the application:

a. Failure to satisfy all of the conditions for the issuance of the EUA;

b. Failure to demonstrate the safety, effectiveness, and quality profile to prevent, diagnose, and treat COVID-19;

c. Failure to settle unresolved problems regarding quality, safety, and effectiveness;

d. Failure to disclose other relevant quality, safety, and effectiveness issues; and

e. The label of the product (including package insert) is false and misleading.

                      The decision to disapprove an application is final and irrevocable. An applicant may re-apply in case of a disapproval of its application for EUA provided that the deficiencies initially noted have been complied.

3. Revocation / Suspension or Cancellation of EUA

a. Violation of pharmacovigilance obligations and post authorization commitments; and

b. Violation of any provision of the Circular and applicable laws, rules and regulations as identified by FDA.

In case of revocation, cancellation or suspension of EUA, the Uniform Rules of Procedure under R.A. No. 9711 shall apply.

G. Validity

The EUA shall be valid only within the duration of the declared public health emergency due to COVID-19, or upon issuance of full market authorization/Certificate of Product Registration.

In the event that the declared public health emergency is lifted, or when a COVID-19 drug or vaccine is registered with the FDA, any issued EUA shall have a provisional validity for a period of one (1) year from date of lifting of the declaration or registration of the drug or vaccine for the sole purpose of exhausting remaining products.

The foregoing is without prejudice to the discretion of the Director General to revisit or revoke any issued EUA, as may be appropriate, to protect the general public health and safety.

H. Post Authorization

  1. Lot Release

The holder of the EUA of COVID-19 Vaccines shall ensure that a complete Summary Lot Protocol which contains the manufacturer’s production data and quality control test results, and recognition/acceptance of Lot Release Certificate from the country of origin (responsible NRA/NCL) or its equivalent is submitted to FDA.

  1. Monitoring

The holder of the EUA has the ultimate responsibility for monitoring the safety of their products. These responsibilities include inventory control and maintenance of appropriate storage until delivery, among others.

The FDA together with concerned offices of the DOH shall conduct post-authorization monitoring to track product deployment, additional relevant information, and the status from the manufacturer concerning full-product life-cycle. Post-authorization monitoring shall include adverse events following immunization (AEFI) or adverse drug reactions (ADR).

  1. Commitments of the Holder of the EUA

a. Complete specific pharmacovigilance obligations (ongoing or new studies, or additional activities) with a view to providing comprehensive data confirming a positive benefit-risk balance. Pharmacovigilance obligations shall adhere to the guidelines and subsequent circulars as issued by the FDA;

b. Complete pending studies and trials. The holder of the EUA shall subsequently proceed to a marketing authorization following FDA guidelines on the condition that it has proven to be safe and effective for the proposed indication;

c. Complete unavailable documents or submit additional necessary documents as may be required by FDA, including provision of further data and response to inquiries; and

d. Secure Lot/Batch Release Certification for all biologicals from the FDA prior to distribution.

  1. Pharmacovigilance

The holder of the EUA shall have a comprehensive pharmacovigilance system for their product following the system or protocol for of a registered drug and biological product.

The holder of the EUA shall ensure compliance with the Risk Management Plan (RMP) including additional pharmacovigilance activities. A summary of RMP shall be provided containing information on product safety profile and explain the measures to characterize the risk including ongoing, new studies or additional activities. The summary of RMP shall be published in the FDA website.

  1. Post Authorization Changes

Any deviation from or changes to the manufacture and changes in label of the product must be notified with the FDA.

  1. Responsibility of the national procurer and health program implementors

The pharmacovigilance obligations and post-authorization commitments of the holder of the EUA shall be shared by the national procurer and health program implementors to the fullest extent possible and applicable.

I. Fees

The fee for application for EUA is P50,000.00 + LRF*

*LRF is equivalent to one percent (1%) of the filing fee imposed, but in no case lower than ten pesos.

VII. SEPARABILITY CLAUSE

If any provision in this Circular, or application of such provision to any circumstances, is held invalid, the remainder of the provisions in this Circular shall not be affected.

VIII. REPEALING CLAUSE

All rules and regulations contrary to or inconsistent with the provisions of this Circular are hereby repealed, modified or amended accordingly.

IX. EFFECTIVITY

This Circular shall take effect immediately following its publication in at least one (1) newspaper of general circulation, and upon submission to the University of the Philippines Office of National Administrative Register (UP-ONAR).

Attachment:-> FDA Circular No.2020-036

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2020-036 || Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19

FDA Circular No. 2020-032 || Renaming of the Center for Cosmetics Regulation and Research to Include Jurisdiction Over Household/Urban Hazardous Substances in its Title Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”

  1. Rationale

Pursuant to Book I, Article VII, Sec. 1 of the Implementing Rules and Regulations (IRR) of the Republic Act (RA) No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, there shall be, under the Office of the Director-General, four (4) Centers covering the four (4) major product categories that are regulated under FDA. Among the four (4) Centers is the Center for Cosmetics Regulation and Research (to include household/urban hazardous substances), which shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of cosmetics and household/urban hazardous substances. The Center shall likewise conduct research on the safety and quality of cosmetics and household/urban hazardous substances, and institute standards for the same.

There is a need to rename the title of the Center for Cosmetics Regulation and Research to provide clarity on the scope of its jurisdiction, covering cosmetics and household/urban hazardous substances in accordance with the law.

  1. Declaration

Consistent with the provisions of RA 9711 and Its IRR, it is hereby declared that the Center for Cosmetics Regulation and Research shall now be referred to as the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research.

All internal and external communications, authorizations, certifications, orders, advisories, and other legal documentations, as applicable, shall reflect the above title accordingly.

Nothing in this issuance shall authorize the creation of a new Center or Office within the Food and Drug Administration. The renaming shall only affect the title of the Center, and shall not extend to creation of new, or modification of existing organizational structure, mandate, functions, powers, and duties accorded to the Center.

  • Effectivity

This Circular shall take effect immediately following the completion of its publication in a newspaper of general circulation and submission of a copy hereof to the University of the Philippines Office of the National Registry (UP-ONAR).

Attachment:-> FDA-Circular-No.2020-032

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2020-032 || Renaming of the Center for Cosmetics Regulation and Research to Include Jurisdiction Over Household/Urban Hazardous Substances in its Title Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”

ANNOUNCEMENT || ONLINE PUBLIC CONSULTATION ON THE DRAFT IMPLEMENTING GUIDELINES OF ADMINISTRATIVE ORDER NO. 2019—0010, “GUIDELINES ON THE REGULATION OF OPERATORS OF PEST CONTROL, CERTIFICATION OF PESTICIDE HANDLERS, AND ACCREDITATION OF THEIR TRAINING PROVIDERS”

In the interest of the service, the Center for Cosmetics Regulation and Research (CCRR), Food and Drug Administration (FDA), shall conduct an “Online Public Consultation on the Draft Implementing Guidelines for the Issuance of License to Operate as Pest Control Operators for Non-Agricultural Purposes, Certification of Pesticide Handlers, and for Other Purposes” on 21 October 2020 (9:00 AM – 12:00 NN), via Google Meet.

All concerned stakeholders are invited to participate by registering through this link: https://bit.ly/31eSXtL .

The activity shall be on a first-come, first-serve basis as the online platform can only accommodate a maximum of one-hundred (100) participants. To maximize the number of attendees, please limit your representative to only one (1) per company/industry association.

For any concerns or inquiries, kindly contact CCRR at (02) 8857-1900 local 8107 or 8113, or through email at [email protected] .

For your information and guidance.

Attachment:->  Announcement re. Online Public Consultation on the Implementation of AO 2019-0010

 

/ In Circular / By FDA Admin3 / Comments Off on ANNOUNCEMENT || ONLINE PUBLIC CONSULTATION ON THE DRAFT IMPLEMENTING GUIDELINES OF ADMINISTRATIVE ORDER NO. 2019—0010, “GUIDELINES ON THE REGULATION OF OPERATORS OF PEST CONTROL, CERTIFICATION OF PESTICIDE HANDLERS, AND ACCREDITATION OF THEIR TRAINING PROVIDERS”

FDA Circular No. 2020-0030 || Guideline for the Use of the FDA eServices Portal System for License to Operate (LTO) Application of Drug Distributors,Drug Traders, Drugstores, Retail Outlets for Non-Prescription Drugs (RONPD), Clinical Research Organizations (CRO), and Sponsors

 

  • RATIONALE

 

The Department of Health (DOH) issued Administrative Order (AO) No. 2020-0017 entitled “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003” to provide simplified and streamlined regulatory requirements and procedures in applying for License to Operate (LTO) of FDA-regulated establishments. This is in compliance with RA No. 11032, otherwise known as, “Ease of Doing Business and Efficient Government Service Delivery Act of 2018” which aims to promote transparency in the government, re-engineering of systems and processes to expedite business and non-business related transactions, and pursuant to RA No. 8792 or the “Electronic Commerce Act of 2000” that promotes the universal use of electronic transaction in the government services, among others.

Attachment:-> FDA-Circular-No.-2020-030

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2020-0030 || Guideline for the Use of the FDA eServices Portal System for License to Operate (LTO) Application of Drug Distributors,Drug Traders, Drugstores, Retail Outlets for Non-Prescription Drugs (RONPD), Clinical Research Organizations (CRO), and Sponsors

FDA Circular No. 2020-0029 || Guidance on Applications for the Conduct of COVID-19 Clinical Trials

    1. INTRODUCTION

     

    The coronavirus disease (COVID-19) outbreak has been declared a pandemic. Undeniably, the country is in the midst of an emergency brought by the COVID-19 situation posing clear and present risks to the health and lives of the general public. A global search for an effective treatment and vaccine is on the race to save the lives of infected people against this emerging disease.

    Prior the surge of the pandemic, the Food and Drug Administration (FDA) undertook to create a clear, simplified, and transparent regulation on the conduct of clinical trials. As thus, Administrative Order (A.O.) No. 2020-0010 otherwise known as “Regulations on the Conduct Clinical Trials for Investigational Products” was published.

    In light of the current pandemic and to further align the current regulatory processes of the FDA with the policies of the Inter-Agency Task Force for the Management of Emerging Infectious Disease Resolution and the Department of Science and Technology, this Circular is hereby issued to guide researchers in navigating the regulatory landscape for COVID-19 related clinical trials.

     Read more:-> FDA Circular No. 2020-029

     

FDA Circular No. 2020-015-B || Further Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”

On 21 April 2020, FDA Circular No. 2020-015 was issued to provide interim measures to ensure access to vitamin drug products during the Coronavirus Disease 2019 (COVID-19) Pandemic. Subsequently, FDA Circular No. 2020-015-A was issued to extend the validity of said Circular.

Considering that there are regular updates on the quarantine status of different localities in the country, the validity of the provisions of this Circular should remain unaffected to ensure access to vitamin drug products during the COVID-19 pandemic.

Hence, FDA Circular No. 2020-015 shall be valid until 31 December 2020, regardless of the level of the imposed quarantine restriction, and subject to extension upon the review of this Office.

Attachment–>FDA-Circular-No.2020-015-B

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2020-015-B || Further Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”

FDA Circular No.2020-007-B || Further Amendment to FDA Circular No. 2020-007 entitled “Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”

On 17 March 2020, FDA Circular No. 2020-007 was issued providing guidelines for the implementation of the use of electronic means of prescription for drugs for the benefit of individuals vulnerable to COVID-19. Thereafter, on 26 August 2020, FDA Circular No. 2020-007-A was issued to extend the validity of said Circular.

Considering that there are regular updates on the quarantine status of different localities, the validity of the provisions of this Circular should remain unaffected to ensure access to drugs for the benefit of vulnerable individuals to COVID-19.

Hence, FC No. 2020-007 shall be valid until 31 December 2020, regardless of the level of the imposed quarantine restriction, and subject to extension upon the review of this Office.

Attachement–>FDA-Circular-No.2020-007-B

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No.2020-007-B || Further Amendment to FDA Circular No. 2020-007 entitled “Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”

FDA Circular No. 2020-028 || Reissuance of the Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)

I. RATIONALE

On 02 April 2020, FDA Circular No. 2020-012 was issued to provide guidelines for the registration of Drug Products Under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19). Said Circular was further amended by FDA Circular Nos. 2020- 012- A and 2020-012-B on 27 July 2020 and 26 August 2020, respectively.

The global search for an effective treatment against this emerging disease continues until today. The clinical management for treatment of suspected or confirmed cases is continuously being updated based on the Philippine Society for Microbiology and Infectious Diseases (PSMID) for the Clinical Management of Adult Patients with Suspected or Confirmed COVID-19 Infection. Also, R.A. No. 11494, otherwise known as the “Bayanihan to Recover As One Act” (“Bayanihan 2” for brevity) authorizes necessary and proper exercise of powers to ensure the availability of medicines in the supply chain [Section 4(dd)]. Thus, there is a need to reissue and update current regulations on the registration of drug products under emergency use to ensure access to the same at all times, regardless of the imposed quarantine restrictions. The need of the public for access to quality, safe, and effective medicines for the COVID-19 disease remains.

II. OBJECTIVE

This Circular aims to provide streamlined requirements and application process for the registration of Drug Products under Emergency Use (DEU) for COVID-19.

III. SCOPE AND COVERAGE

This Circular shall be applicable to all Marketing Authorization Holders (MAH) intending to manufacture and import/distribute the drug products listed in the PSMID Interim Guidelines on the Clinical Management of Adult Patients with Suspected or Confirmed COVID-19 Infection. These are the only considered Drug Products under Emergency Use (DEU) for the pandemic:

The drug product eligible for registration under DEU is as follows:

Generic Name Dosage Form and Strength
Tocilizumab 400 mg/ 20 mL Concentrate Solution for I.V. Infusion
200 mg/ 10 mL Concentrate Solution for I.V. Infusion
80 mg/ 4 mL Concentrate Solution for I.V. Infusion
162 mg/ 0.9 mL Solution for Injection (S.C.)

New applications for the registration of Chloroquine, Hydroxychloroquine, and Lopinavir + Ritonavir under DEU registration shall no longer be accepted.

Current stocks at the manufacturing level of those issued with Certificate of Product Registration (CPR) shall be exhausted for their approved indications within the given validity. No further extension shall be granted. Furthermore, the inventory of stocks on hand shall be submitted as required under FDA Circular No. 2020-013.

The list shall be updated following any change/s in the above-stated treatment guidelines.

IV. GUIDELINES

A. Eligibility Criteria

The DEU shall be locally manufactured or imported and distributed for the management of COVID-19 patients during the pandemic, following the PSMID Interim Guidelines.

B. Documentary Requirements

Only the following requirements shall be submitted by the MAHs:

1. Integrated Application Form (in excel and in pdf format)
2. Letter of Intent
3. Valid License to Operate of Drug Manufacturer/Repacker/Packer/Trader (for locally manufactured products) or Drug Importer (for imported products)
4. Certificate of Pharmaceutical Product or Certificate of Free Sale (for imported products)
5. List of countries where the product is marketed (for biologicals)
6. Certificate of Foreign Good Manufacturing Practice (GMP) Clearance duly issued by this Office and/or GMP Certificate issued by the national regulatory authority or other competent regulatory authority (for imported products)
7. Labeling Materials
8. Generic Labeling Exemption may be granted for products exceeding 12,000 units.
9. Product Composition/Formulation (Unit Dose and Batch Formulation)
10. Finished Product Technical Specifications
11. Finished Product Certificate of Analysis (CoA) and Batch Analysis
12. Stability Studies
13. Drug products with no stability studies shall be given an interim shelf-life of 6 months.
14. Proof of Payment (Official Receipt or Landbank Oncoll Payment Slip)

C. Application Process

There shall be no need for the scheduling of submission of applications under this Circular. Applications for the registration shall be under Emergency Use Classification and shall be submitted at the Food Drug Action Center (FDAC). Submission of applications may be done either:

Manual submission to FDAC. Submit the requirements in a flash drive at the FDAC – PACD. An Acknowledgement Receipt with a corresponding Document Tracking Number shall be issued to the applicant.

E-mail submission. The applicant shall submit the application through [email protected] Guidance for e-mail submission shall be specified in a separate issuance.

D. Fees

The appropriate fees as prescribed under existing regulations shall apply, including the Legal Research Fund (LRF).

Application Type Fees
Emergency Use Registration Php 5,000.00 + LRF
Brand Name (if any) Php 500.00 + LRF per brand name

E. Validity of the Certificate of Product Registration (CPR)

The CPR shall be valid for one (1) year under Emergency Use Registration Status and is not subject for renewal registration. Automatic revocation of the CPR shall be imposed at the end of the pandemic.

F. Post-Approval Compliance

Post-Approval Compliance to the CPR shall be strictly required from the MAHs.

1. Post-Approval Commitments – shall be submitted within the CPR validity, or as prescribed below:

a. Post-Approval Stability Data of Commercial Batch/es for products without stability data submitted upon its registration
b. Commercial sample from the first batch of manufacture (local) or importation shall be submitted to this Office prior to distribution
c. Reference standards of the Active Pharmaceutical Ingredient/s (API) – submission shall be within five (5) working days from the CPR issuance

2. Post-Market Surveillance (PMS)

Health institutions (Hospitals, other Health Facilities) and Healthcare Professionals that shall use the products approved under this Circular shall be coordinate and submit to the respective suppliers/MAH for Adverse Drug Reaction (ADR) reports. The MAH shall be responsible for the submission of the ADR reports consistent with the latest issuance with this Office.

The MAH shall undertake the PMS activities in a separate issuance.

G. Supplemental Information

As interim measures for applications and transactions during the community quarantine, electronic signatures in documents shall be temporarily allowed. The requirement for notarized documents shall also be temporarily suspended. Instead, the applicant shall be required to submit a commitment letter for the submission of the notarized documents once available.

V. REPEALING CLAUSE

In the event that any provision or part of this Circular is declared unauthorized or rendered invalid by any court of law, those provisions not affected by such declaration shall remain valid and effective.

VI. EFFECTIVITY

This Circular shall take effect immediately and shall be effective until 31 December 2020, regardless of the level of the imposed quarantine restrictions due to COVID-19.

Attachment–>FDA-Circular-No.2020-028

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2020-028 || Reissuance of the Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)

FDA Circular No. 2020-015-A || Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”

On 21 April 2020, FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic” was issued. The said Circular provided interim guidelines for the registration and certification of vitamin products in response to the shortage of supplies in the market brought upon by the limited production and supplies due to the enhanced community quarantine (ECQ).

Due to the regular updates to the quarantine status of the different cities and municipalities, the provisions of this Circular may still deemed be applicable and necessary by the public’s interest.

In view of the foregoing, the provisions of FDA Circular No. 2020-015 shall be effective until 31 December 2020, subject for extension upon the review of this Office.

Attachment:-> FDA Circular No.2020-015-A

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-015-A || Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”

FDA Circular No. 2020-012-B || Further Amendment to FDA Circular (FC) Nos. 2020-012 and 2020-012-A entitled “Guidelines for the Registration of Drug, Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)”

The FDA Circular (FC) Nos. 2020-012 and 2020-012-A were issued to provide DEU registration guidelines for selected drug products identified under the Philippine Society for Microbiology and Infectious Diseases (PSMID) Clinical Practice Guidelines (CPG) on COVID-19.

Due to the regular updates to the quarantine status of the different cities and municipalities and in the event that the imposed quarantine is lifted, the provisions of this Circular may still deemed be applicable and necessary by the public’s interest.

In view of the foregoing, the effectivity of FC Nos. 2020-012 and 2020-012-A shall be until 31 December 2020, subject for extension upon the review of this Office.

Read more:-> FDA Circular No.2020-012-B

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-012-B || Further Amendment to FDA Circular (FC) Nos. 2020-012 and 2020-012-A entitled “Guidelines for the Registration of Drug, Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)”

FDA Circular No. 2020-007-A || Amendment to FDA Circular (FC) No. 2020-007 entitled “Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”

In ensuring the continuous access of prescription drugs to individuals vulnerable to COVID-19, the FDA Circular No. 2020-007 was issued to provide guidelines to consumers and health providers on the use of electronic prescription.

Due to the regular updates to the quarantine status of the different cities and municipalities and in the event that the imposed quarantine is lifted, the provisions of this Circular may still deemed be applicable and necessary by the public’s interest.

In view of the foregoing, the effectivity of FC No. 2020-007 shall be until 31 December 2020, subject for extension upon the review of this Office.

Attachment:-> FDA Circular No.2020-007-A

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-007-A || Amendment to FDA Circular (FC) No. 2020-007 entitled “Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”

FDA Circular No. 2020-025 || Implementing Guidelines for Administrative Order No. 2019-0019, “Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products”

 OBJECTIVE:

This Circular aims to:

  1. Establish the guidelines for the licensing and inspection of HUHS establishments;
  2. Establish the guidelines for registration and other relevant authorizations for HUHS products;
  3. Update the categorization of HUHS products;
  4. Institutionalize the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) as the new hazard category for labeling of HUHS products; and
  5. Ensure compliance of HUHS establishments to FDA regulatory standards, such as but not limited to Good Manufacturing Practice (GSP); or Good Distribution Practice (GDP), or Good Storage Practice (GSP); or Good Labeling Practice (GLP).

Read more:->FDA Circular No.2020-025

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-025 || Implementing Guidelines for Administrative Order No. 2019-0019, “Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products”

FDA Circular No. 2020-027 || Conduct of Risk-Based Local Inspections in Light of the COVID-19 Pandemic

OBJECTIVES

This Circular aims to provide guidelines on the conduct of risk-based local inspections to carry out the FDA’s regulatory mission while protecting the health, safety, and well-being of the inspectors and the public.

Read more:->FDA Circular No. 2020-027

FDA Circular No. 2020-026 || Food and Drug Action Center (FDAC) New Normal Operational Guidelines of the Food and Drug Administration (FDA)

1.     RATIONALE

Pursuant to DOH AO No. 2020-0015 known as “Guidelines on the Risk-Based Public Health Standards for COVID-19 Mitigation”, the FDA has been strictly implementing minimum health standards and health safety protocols to prevent the transmission of COVID-19 and other infectious diseases.

The alarming increase in the number of infections due to COVID-19 poses a threat to the health and safety of employees and clients of FDA.  With the recent developments and consultation with internal and external stakeholders, the following guidelines shall be enforced to safely continue serving our clients and to ensure the safety of everyone.

2.     OBJECTIVE

The objective for the issuance of this Order is to provide clear and consistent guidelines for the safety of FDA employees and clients in order to prevent infection and the spread of COVID-19 and other infectious diseases at the FDAC.

3.     SCOPE

This Order shall cover all FDA clients from the industries transacting business at the FDAC and FDA employees or staff providing regulatory services at the FDA.

Read more:-> FDA Circular No. 2020-026
Attachment:-> Annex C – Notification Form for Minor Variation/s of Registered Pharmaceutical Product

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-026 || Food and Drug Action Center (FDAC) New Normal Operational Guidelines of the Food and Drug Administration (FDA)

FDA Memorandum Circular No. 2020-001-B || Extension of the Effectivity of FDA Memorandum Circular No. 2020-001 entitled “Interim Guidelines for the Issuance of Provisional License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing Alcohol Products under the Center for Cosmetics Regulation and Research” issued on 19 March 2020 and Its Amendment, FDA Memorandum Circular No. 2020-001-A issued on 16 April 2020

In the interest of service and in recognition of the continuing challenges and efforts to address the COVID-19 pandemic, the Food and Drug Administration hereby extends the effectivity of Memorandum Circular No. 2020-001 entitled “Interim Guidelines for the Issuance of Provisional License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing Alcohol Products under the Center for Cosmetics Regulation and Research” issued on 19 March 2020 and its amendment, FDA Memorandum Circular No. 2020-001-A issued on 16 April 2020 until 31 December 2020.

For information and guidance.

Attachment:-> FDA Memorandum Circular No. 2020-001-B

SEE ALSO -> FDA Memorandum Circular No. 2020-001
SEE ALSO -> FDA Memorandum Circular No. 2020-001-A

/ In Circular / By Administrator / Comments Off on FDA Memorandum Circular No. 2020-001-B || Extension of the Effectivity of FDA Memorandum Circular No. 2020-001 entitled “Interim Guidelines for the Issuance of Provisional License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing Alcohol Products under the Center for Cosmetics Regulation and Research” issued on 19 March 2020 and Its Amendment, FDA Memorandum Circular No. 2020-001-A issued on 16 April 2020

FDA Circular No. 2020-024 || UPDATED GUIDELINES FOR APPLICATION OF AUTHORIZATIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATIONS

I.  RATIONALE

The Food and Drug Administration (FDA) issued Circular No. 2020-006 entitled “Guidance for Applications and Transactions at the Food and Drug Administration in Light of the Community Quarantine Declaration on 17 March 2020 and its amendments, Circular No. 2020-006-A on 2 April 2020 and Circular No. 2020-006-B on 17 July 2020 as the Agency’s response to the Community Quarantine declaration.

In view of the interim changes brought about by the COVID-19 pandemic in the agency and its regulated entities, this Circular is hereby issued to reinforce the guidelines and ensure the continuity of services while protecting the internal and external stakeholders of FDA.

II.  SCOPE AND COVERAGE

This Circular shall cover the general public, all stakeholders applying for FDA authorizations and other stakeholders who are required to submit documents, scheduled to appear at FDA for compliance/meetings, and/or pay appropriate fees and charges.

For purposes of these Guideline, “Community Quarantine” shall mean the Enhanced Community Quarantine (ECQ), the Modified Enhanced Community Quarantine (MECQ), the General Community Quarantine (GCQ), and local community quarantines declared in accordance with IATF Guidelines.

III.  GUIDELINES

A.  Application for License to Operate

1.  Initial Application

 a.  Initial LTO application shall be processed online through the FDA ePortal System. Priority shall be given to establishment with function intended for use in the diagnosis, cure, mitigation, treatment, prevention, and personal protective equipment (PPE) of COVID-19, and essential medicine.

b.  Initial LTO applications of manufacturers of health products shall await pre-license inspection schedule as soon as the community quarantine of the respective Local Government Unit of the establishment is lifted. Exemption to this shall be given to establishment with health products intended for use in the diagnosis, cure, mitigation, treatment, prevention, and personal protective equipment (PPE) of COVID-19, and essential medicines.

c.  The conduct of all foreign inspections for the Year 2020 shall be deferred until further notice pending the lifting of the travel restrictions being imposed in the Philippines and the other countries concerned. A separate issuance shall be issued for this matter.

2.  LTO Renewal Application

a.  LTO expiring on 01 July 2020 to 31 December 2020 shall be given additional four (4) months validity extension from the date of expiration of the market authorization. The applicant shall still apply for the renewal application within the given validity extension period without surcharge.

b.  Renewal application received beyond the 4-month validity extension up to a maximum of one hundred twenty (120) days shall be subject to surcharge as prescribed in the Republic Act (RA) No. 9711 Implementing Rules and Regulations (IRR) and FDA issuances.

c.  Any application for renewal received thereafter shall be considered expired and the application shall undergo initial filing and evaluation procedure, subject to applicable fees as prescribed in the RA NO. 9711 IRR and FDA issuances.

d.  For transactions with the Bureau of Customs, this Circular shall be attached in support to the authorization which expired during the mentioned period.

 B.  Application for Certificate of Product Registration/Notification (CPR/CPN)

  1. Initial Application

Initial CPR/CPN application shall be processed online through the FDA ePortal System, as applicable. Priority shall be given to health products intended for use in the diagnosis, cure, mitigation, treatment, prevention, and PPE of COVID-19, and essential medicine.

  1. Renewal Application
  1. CPR/CPN expiring on 01 July 2020 to 31 December shall be given additional four (4) months validity extension from the date of expiration of the market authorization. These applicants, however, shall apply for renewal within the given extension period.
  2. Renewal application received beyond the 4-month validity extension up to a maximum of one hundred twenty (120) days shall be subject to surcharge as prescribed in the Republic Act (RA) No. 9711 Implementing Rules and Regulations (IRR) and FDA issuances.
  3. Any application for renewal received thereafter shall be considered expired and the application shall undergo initial filing and evaluation procedure, subject to applicable fees as prescribed in the RA NO. 9711 IRR and FDA issuances.
  4. The automatic validity extension shall not preclude the FDA from revoking the relevant market authorization if the evaluation of the application so warrants.
  5. For transactions with the Bureau of Customs, this Circular shall be attached in support to the authorization which expired during the mentioned period.

Specific guidelines on initial and renewal CPR applications applicable on health product category and/or their Center of jurisdiction shall be issued on a separate issuance.

 C.  Application for other Market Authorizations/Certificates/Permits

Application for other Market Authorizations shall be done electronically, as applicable. Specific guidelines on filing of applications shall be issued on a separate issuance.

D.  Payment of Fees and Charges

  1. Over-the-counter payments shall be suspended during the community quarantine period.
  2. Payment of fees as indicated in the Order of Payment (OP) maybe done thru On-Coll payment at Land Bank of the Philippines (LBP) branches, or online payment thru Bancnet Online Payment Facility (including LBP bills payment).E.  Release of FDA Market Authorizations and Certificates
  1. Results of applications and scanned copy of FDA market authorizations and certificates shall be sent to the registered email of the company’s authorized representative.
  1. For clients within the National Capital Region (NCR), authorizations shall mailed thru courier to the registered mailing address of the Company.

For clients outside of the NCR, authorizations will be mailed thru courier to the respective Regional Field Office (RFO) which has jurisdiction over the concerned Company.

IV.  SEPARABILITY CLAUSE

If any provision or part of this Circular or the application of such provision to any individual or entity is declared invalid or unconstitutional by the proper authorities, the remaining provisions not affected by such declaration shall remain in effect.

All directives previously released or implemented by FDA pertaining to the extension, interruption or movement of the periods and timelines set by law, rules and regulations for the filing of documents, conduct of proceedings, payment of fees and other charges are hereby adopted insofar as they are consistent with the guidelines set forth by the IATF and the directives of the Office of the President.

 V.  REPEALING CLAUSE

Provisions of FDA Circular No. 2020-006, its amendment, and other previous issuances inconsistent with this Circular are hereby repealed, rescinded and modified accordingly.

 VI.  EFFECTIVITY

This Circular shall take effect immediately. The provisions stated herein, as well as those stated in FDA Circular No. 2020-006, FDA Circular No. 2020-006-A, and FDA Circular 2020-006-B shall remain in effect until the lifting of the Public Health Emergency declaration in the Philippines or as recommended by the IATF.

For compliance.

Attachment:->FDA Circular No.2020-024.

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-024 || UPDATED GUIDELINES FOR APPLICATION OF AUTHORIZATIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATIONS

FDA Circular No. 2020-022 || REISSUANCE OF THE GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCY

I.  INTRODUCTION

On 18 March 2020 FDA Circular No. 2020-009, entitled Guidelines othe Identification, Notification, Evaluation, Regulatory Enforcement Action, and Review and Monitoring of Donated Health Products Solely Intended to Address COVID-19 Public Health Emergency” was issued to expedite the processing of donations of certain COVID-19 health products.

Various amendments have been introduced to the Circular after its issuance. Ventilators and respirators were added to the list of covered health products (FDA Circular Nos. 2020-009-A and 2020-009-B). Also, the effectivity of said Circular was extended until 31 August 2020 (FDA Circular No. 2020-009-C).

As the Corona Virus Disease (COVID-19) continues to pose a threat to the health and safety of the public, a reissuance of the Guidelines becomes necessary.

II.  OBJECTIVE

This Circular aims to provide the guidelines on the identification, notification, evaluation, regulatory enforcement action, and review and monitoring of donated health products solely intended to address COVID-19 public health emergency.

III.  BASES

This Circular is issued pursuant to Department of Health (DOH) Administrative Order No. 2007-0017 dated 28 May 2007,[1] pursuant to the authority and mandate of the Food and Drug Administration (FDA) to protect and promote the right to health of the Filipino people under the 1987 Constitution and Republic Act No. 3720, as amended by Executive Order No. 175 and Republic Act No. 9711, Republic Act No. 11332[2], and Republic Act No. 10121.[3]

 IV.  SCOPE

This Circular implements the process of identification, notification, evaluation, review and monitoring and other regulatory or enforcement action of FDA covering foreign or locally donated health products solely intended to address the COVID-19 public health emergency.

This Circular applies only to the following health products:

  1. Face Masks including N-95 Masks,
  2. Shoe Covers,
  3. Gloves,
  4. Head Covers,
  5. Gowns,
  6. Goggles/ Face Shields,
  7. COVID-19 Diagnostic Test Kits,
  8. Alcohol, Hand Sanitizers, Soaps, etc.,
  9. Ventilators, Respirators, their respective Accessories, and Respiratory Devices, and
  10. Other health products that may hereinafter be identified and listed by the FDA.

All the offices within the FDA, principally the Food and Drug Action Center (FDAC), Center for Drug Regulation and Research (CDRR), Center for Device Regulation, Radiation Health, and Research (CDRRHR), Center for Cosmetics Regulation and Research (CCRR), Center for Food Regulation and Research (CFRR), Field Regulatory Operations Office (FROO), and Testing Laboratories  are mandated to perform, with dispatch, their respective functions in implementing this Circular.

V.  GUIDELINES

 A.  Identification of covered health products

  1. The health products identified and listed above are covered by this Circular, whether locally or foreign donated.
  2. The CDRR, CDRRHR, CCRR and CFRR shall identify and recommend other health products that may be covered by this Circular hereinafter.
  3. Once the recommendation is approved, the FDA shall provide a listing and shall form part of this Circular.

B.  Notification

  1. Documentary requirements for donations provided in DOH Administrative Order No. 2007-0017 or the “Guidelines on the Acceptance and Processing of Foreign and Local Donations During Emergency and Disaster Situations” shall be received by the FDAC for notification purposes.
  2. Once the complete set of documents has been received by FDAC from the DOH, the donated covered health products are immediately deemed cleared as required under Administrative Order No. 2007-0017. The receiving copy of such documents shall be bear the note/stamp ‘RECEIVED AND CLEARED FOR “COVID-19” DONATION PURPOSES,’ and shall be sufficient clearance from the FDA. However, the donated products shall be subject to post-notification evaluation and further regulatory or enforcement action by the FDA.
  3. All documents received by the FDAC shall be endorsed to the appropriate Center with urgency.

C.  Post-notification Evaluation

  1. Once endorsed, the appropriate Center shall evaluate the documents and notify the FROO for the collection of samples.
  2. The assigned inspector(s) shall expediently collect samples and forward the same to the appropriate Center and to the Laboratory in case testing is required.
  3. Should testing be required, the Testing Laboratories shall immediately conduct the appropriate analysis/assay and issue the corresponding report. The report including results of evaluation shall be forwarded to the Bureau of International Health Cooperation (BIHC) or other assigned DOH Office, as may be proper.

The receipt, endorsement to the appropriate Center, evaluation by the Centers and issuance of reports shall in no case exceed forty eight (48) hours.

D.  Regulatory Enforcement Action

  1. If evaluation shows that the health product is unsafe or unfit for the purpose it is intended, immediate regulatory or enforcement action shall be pursued by the FROO in coordination with the concerned Center. Regulatory or enforcement action shall include, recall, seizure, and/or filing of legal case before the FDA or in
  2. Close coordination by the FROO with Bureau of Customs (BOCs), DOH, Local Government Units (LGUs), Law Enforcement Agencies, and other concerned government agencies is mandated.

 E.  Review and Monitoring

The Policy and Planning Service (PPS), in coordination with the concerned Centers and Offices, shall continuously monitor the implementation of this Circular.  Any necessary changes shall be immediately recommended to the Office of the Director General for approval.

All involved Centers and Offices shall submit reports to the Office of the Director General every 48 hours or earlier as necessary of any development in the implementation of this Circular.”

 VI.  REPEALING AND SEPARABILITY CLAUSE

FDA Circular No. 2020-009, and its amendments, and all other provisions in existing circulars and memoranda are hereby withdrawn, repealed and revoked accordingly.

If any provision in this Circular is held invalid, the remainder thereof shall not be affected.

VII.  EFFECTIVITY

This Order shall take effect immediately and shall be in effect until 31 December 2020 unless sooner revoked or extended.

For the information and guidance of all.

Attachment:->FDA Circular No.2020-022

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-022 || REISSUANCE OF THE GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCY

FDA Circular No. 2020-021 || Guidelines for the Acceptance of Certificate of Safety Evaluation (CSE) Applications for Radiofrequency Radiation (RFR) Facilities through the FDA RRD Portal

OBJECTIVES:

This Circular aims to provide implementing guidelines to all relevant stakeholders of the new process in the acceptance of applications of CSE for RFR facilities pursuant to DOH AO No. 2020-0035.

Read more:->FDA Circular No. 2020-021

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-021 || Guidelines for the Acceptance of Certificate of Safety Evaluation (CSE) Applications for Radiofrequency Radiation (RFR) Facilities through the FDA RRD Portal

FDA Circular No. 2020-012-A || Amendment to FDA Circular No. 2020-012 entitled Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)

Relative to the recent updates of the Philippine Society for Microbiology and Infectious Diseases (PSMID) Clinical Practice Guideline (CPG) on the Interim Management Guidelines for Coronavirus Disease 2019 (COVID-19) Version 3.1 issued on 20 July 2020, the list of Drug Product under Emergency Use (DEU) is hereby amended.

The drug product eligible for registration under DEU is as follows:

Generic Name Dosage Form and Strength
Tocilizumab 400 mg/ 20 mL Concentrate Solution for I.V. Infusion

200 mg/ 10 mL Concentrate Solution for I.V. Infusion

80 mg/ 4 mL Concentrate Solution for I.V. Infusion

162 mg/ 0.9 mL Solution for Injection (S.C.)

New applications for the registration of Chloroquine, Hydroxychloroquine, and Lopinavir + Ritonavir under DEU registration shall no longer be accepted.

Current stocks at the manufacturing level of those issued with Certificate of Product Registration (CPR) shall be exhausted for their approved indications within the given validity. No further extension shall be granted. Furthermore, the inventory of stocks on hand shall be submitted as required under FDA Circular No. 2020-013.

This Circular shall take effect immediately.

Attachment:->FDA Circular No. 2020-012-A

SEE ALSO: FDA Circular No. 2020-012

 

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-012-A || Amendment to FDA Circular No. 2020-012 entitled Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)

FDA Circular No. 2020-011-A || RESCISSION OF FDA CIRCULAR NO. 2020-011 entitled “GUIDELINES OF ALCOHOL BASED SANITIZER FORMULATIONS IN LIGHT OF THE DECLARATION OF STATE OF CALAMITY DUE TO COVID-19”

On 25 March 2020, FDA Circular No. 2020-011, or the “Guidelines on Pharmacy Compounding of Alcohol-Based Sanitizer Formulations in Light of the Declaration of State of Calamity Due to COVID-19,” was issued. Said Circular provides interim guidelines to drugstores/ pharmacies/ boticas for the compounding of alcohol-based sanitizers in response to the need for increased production of such products during the COVID-19 public health emergency.

Considering however that regular supply of alcohol-based sanitizers has been restored, compounding of alcohol products by drugstores/ pharmacies/ boticas is no longer necessary.

In view of the foregoing, FDA Circular No. 2020-011 is hereby rescinded effective immediately.

Attachment:->FDA Circular No.2020-011-A

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-011-A || RESCISSION OF FDA CIRCULAR NO. 2020-011 entitled “GUIDELINES OF ALCOHOL BASED SANITIZER FORMULATIONS IN LIGHT OF THE DECLARATION OF STATE OF CALAMITY DUE TO COVID-19”

FDA Circular No. 2020-006-B || FURTHER AMENDMENT TO THE FDA CIRCULAR NO. 2020-006 ENTITLED “GUIDANCE FOR APPLICATIONS AND TRANSACTIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATION” ISSUED ON 17 MARCH 2020 AND ITS AMENDMENT ISSUED ON 2 APRIL 2020

SCOPE AND COVERAGE

This Circular shall cover all stakeholders applying for FDA Authorizations and other stakeholders who are required to submit documents, scheduled to appear at FDA for compliance/meetings, and/or pay appropriate fees and charges.

Likewise covered by this Circular is the commencement of administrative actions including administrative cases pending evaluation. proceedings, or for decisions involving violations of R.A No. 3720, as amended by R.A. No. 9711 and other FDA-implemented laws, rules and regulations.

This Circular does not cover the proceedings and running of reglementary periods for urgent cases which are necessary to enable the FDA to act expeditiously on matters affecting the current public health emergency, such as any coronavirus disease 2019 (COVID-19) related cases (e.g. violations of the imposed price freeze or ceiling on covered products or those cases pertaining to activities or products regulated by FDA without prior authorization intended for or claiming to address the COVID-19)

For purposes of these Guidelines, community quarantine shall mean the Enhanced Community Quarantine, the General Community Quarantine, and local community quarantines declared in accordance with IATF Guidelines.

 to continue reading,click HERE–>FDA Circular No.2020-006-B

SEE ALSO: FDA Circular No. 2020-006

SEE ALSO: FDA Circular No. 2020-006-A

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-006-B || FURTHER AMENDMENT TO THE FDA CIRCULAR NO. 2020-006 ENTITLED “GUIDANCE FOR APPLICATIONS AND TRANSACTIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATION” ISSUED ON 17 MARCH 2020 AND ITS AMENDMENT ISSUED ON 2 APRIL 2020