Category: Circular

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

FDA Circular No. 2020-020 || Interim Guidelines Governing the Issuance of a Permit to Register to Drug Importers for Foreign Drug Manufacturers

I.   RATIONALE

Consistent with the policy of the State 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 people at affordable cost, Republic Act No. 9502[1] was enacted.

Further, to ensure that essential goods, drug products in particular, that are made available to the people are safe and of quality, Administrative Order (A.O.) No. 2013-0022[2] was promulgated with the aim of creating and implementing systems of evaluation, monitoring, including the conduct of foreign inspections to assure compliance of manufacturers to the Good Manufacturing Practice (GMP) that sells or offers for sale their drug products into the Philippines.  Its implementing guidelines, FDA Circular (F.C.) No. 2014-016, further set out when the conduct of foreign inspection is initiated or triggered.  Under the said FDA Circular, the Center for Drug Regulation and Research, after assessing the submitted applications for GMP Clearance, recommends to FROO for inspection those that have not provided satisfactory GMP evidence[3].  Once confirmed that the facility manufactures the drug products at an acceptable standard (cGMP) and is issued clearance, the foreign manufacturer, through its local importer(s) can now proceed to register before the FDA its drug product before making them available for commercial distribution locally.

The Coronavirus disease 2019 (COVID-19) pandemic has triggered national and international restrictions that prevent the conduct of certain on-site GMP inspections.  This health pandemic has put every country and everyone in an extraordinary situation and with the still increasing number of confirmed COVID-19 cases worldwide and imposed international travel restrictions, the conduct of the foreign inspection in accordance with F.C. No. 2014-016 has been rendered completely not feasible.

Consequently, and with the utmost consideration of the welfare and protection of the Drug GMP Inspectorate Task Force on the one hand, while on the other hand, the duty to implement the policy of ensuring availability of and access to essential goods, it becomes imperative to issue interim guidelines to facilitate the registration  not only of COVID-19 related drug products, but also other essential and life-saving drug products. Hence, this Circular.

II.   OBJECTIVE

This Circular shall provide the interim guidelines for the thorough evaluation of submitted applications for GMP Clearance which was recommended for inspection, and the appropriate action thereto to facilitate drug product registration of drug importers due for inspection of foreign manufacturers, which inspection cannot be pursued due to the compelling reasons of protecting the safety and welfare of the Drug GMP Inspectorate Task Force and international travel restrictions brought by the COVID-19 pandemic.

In issuing this Circular, the FDA hereby consistently reiterates its mandate to ensure the safety, efficacy, and good quality of pharmaceutical products applied for registration and made available to the consuming public.

 III.   SCOPE

This Circular shall apply to all initial applications for GMP Clearance of drug importers and foreign drug manufacturers, with issued Notice for Foreign Inspection (NFI) and have paid the application fee for Foreign Drug Manufacturer Inspection.

Furthermore, this shall also cover the Center for Drug Regulation and Research (CDRR), Field Regulatory Operations Office (FROO), Drug GMP Inspectorate Task Force and other concerned Offices within the FDA.

IV.   GUIDELINES

  1. The conduct of foreign inspection in accordance with F.C. No. 2014-016 is temporarily suspended for a period of one year from date of effectivity of this Circular unless sooner lifted.
  1. The submitted updated GMP evidences of drug importers issued with NFI shall be subjected to thorough evaluation and review by the Drug GMP Inspectorate Task Force of the FROO, provided that a Foreign cGMP clearance shall be issued to manufacturers which have been inspected by Pharmaceutical Inspection Cooperation Scheme (PIC/S), ASEAN Mutual Recognition Agreement (MRA) and part of the WHO Prequalification Program.
  1. A Permit to Register shall be issued to the drug importer for applications found satisfactorily complying with the GMP standards based on document review.

            A Permit to Register shall only be an interim approval to allow the applicant to proceed with the drug product registration. Foreign inspection shall still be conducted notwithstanding the issuance of the Permit to Register once foreign inspection resumes pursuant to paragraph 6, Item V of A.O. No. 2013-0022.

            If found compliant with the cGMP standards during the foreign inspection, a Foreign cGMP Clearance shall be issued. If found non-compliant, a letter of disapproval shall be issued and all product applications and existing CPRs related to the Permit to Register shall be disapproved, suspended, cancelled or revoked.

  1. Those applications which were evaluated to be satisfactory shall be notified to pay 50% of the required inspector’s fee, and shall be issued the Permit to Register upon payment. These applications shall be given priority once foreign inspection resumes.
  1. Applications which are not satisfactory shall not be issued a Permit to Register, and shall be subject for inspection upon resumption of Foreign GMP Inspection.
  1. An incomplete submission of requirements under this Circular shall be denied.
  1. Upon the resumption of on-site foreign inspection, drug importers shall be given a schedule of inspection and a directive to pay the remaining fees.
  1. In case the drug importer intends to withdraw the application for Foreign cGMP Clearance, a written notification shall be submitted to FDA. The withdrawal shall mean abandonment of any application or intent to apply for drug product registration.V. APPLICATION PROCESS
  1. Filing

Applicants with issued NFI and have paid the application fee for Foreign Drug Manufacturer Inspection before July 2020 shall be notified by FROO to submit the following documents to the Food and Drug Action Center (FDAC) within twenty (20) working days from receipt of the notice, otherwise the application is deemed abandoned, resulting to the issuance of a disapproval:

  1. Letter of Intent;
  2. Updated GMP Evidence issued by the Drug Regulatory Authority (DRA);
  3. Updated GMP Evidence Dossier (Annex C of A.O. No. 2013-0022);
  4. Updated duly accomplished Application Form for foreign manufacturer GMP Inspection (Annex D of A.O. No. 2013-0022) should there be any changes in the manufacturer information; and
  5. List of Products to be registered.

On the other hand, applicants with issued NFI beginning July 2020 may submit latest requirements stated above.

  1. Evaluation

Thorough evaluation and review of the updated GMP evidence shall be conducted by the Drug GMP Task Force with verification of the submitted evidence from the issuing DRA, among others. Should there be any clarification to prove compliance, an e-mail shall be sent to the applicant.

If found satisfactorily complying with the GMP standards based on document review, the FROO shall send an assessment slip for the payment of 50% of the inspector’s fee. The required fee shall be paid to the FDA Dollar Account at any DBP branches within twenty (20) working days upon receipt of the assessment slip otherwise, the application is deemed abandoned, resulting to the issuance of a disapproval. Proof of payment shall be submitted to FROO.

Priority shall be given in the following order:

  1. COVID-19 related drug products including vaccines as determined by FDA;
  2. Innovator drug products;
  3. Other Foreign cGMP Inspection applications that were scheduled and have already paid the full inspector’s fee prior to the issuance of this Circular;
  4. First five (5) products of a molecule;
  5. Essential and life-saving drug products with less than five (5) suppliers in the country;
  6. Others wherein the order of evaluation shall follow the order of submission.

The FROO shall evaluate the applications according to the priority provided above. The CDRR shall assist FROO in the evaluation, and if necessary, provide a list of products that shall be prioritized in the evaluation.

  1. Decision

Upon recommendation of FROO, CDRR shall issue the appropriate decision on the application as provided under these Guidelines with notice to the applicant.

VI.   INSPECTOR’S FEES

            The Inspector’s Fees shall be as follows:

Region Inspector’s Fee 50% of the Inspector’s Fee
ASEAN Countries US$ 3,500 US$ 1,750*
Asia-Pacific Countries US$ 7,000 US$ 3,500*
All other countries outside Asia-Pacific US$ 10,500 US$ 5,250*

*The additional current United Nation Development Program – Daily Subsistence Allowance (UNDP-DSA), plane fare and translator’s fee shall be paid in full together with the remaining 50% of the inspector’s fee.

No refunds shall be considered once the appropriate fees have been paid.

VII.  EFFECTIVITY

This Circular shall take effect immediately after publication to a newspaper of general circulation and upon submission to the University of the Philippines Office of National Administrative Register (UP-ONAR), and shall be valid for one year unless sooner revoked.

Attachment:->FDA Circular No.2020-020

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-020 || Interim Guidelines Governing the Issuance of a Permit to Register to Drug Importers for Foreign Drug Manufacturers

FDA Circular No. 2020-009-C || EXTENSION OF EFFECTIVITY OF FDA CIRCULAR 2020-009 ENTITLED “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 COVID-19 pandemic, the effectivity of FDA Circular No. 2020-009 entitled “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 31 August 2020.

For your information and guidance.

Attachment:->FDA Circular No. 2020-009-C

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-009-C || EXTENSION OF EFFECTIVITY OF FDA CIRCULAR 2020-009 ENTITLED “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. 2020-018 || Interim Guidelines of the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators to be used in the COVID-19 Pandemic

I. RATIONALE

Due to the alarming level of spread and severity of Corona Virus Disease (COVID-19), the World Health Organization (WHO) officially declared the virus outbreak a pandemic on 11 March 2020. Subsequently, the President of the Philippines declared a State of Public Health Emergency and State of Calamity due to COVID-19 through Proclamation Nos. 922 and 929, respectively.

Demand for essential medical devices used in the response to COVID-19 such as Personal Protective Equipment (PPE), ventilators and respirators has increased. Said PPE pertains to face masks including N95 masks, shoe covers, gloves, head covers and gowns. On the other hand, the ventilators and respirators include respiratory therapy devices and respective accessories.

In turn, the Food and Drug Administration (FDA) has adopted several measures to ensure adequate access and availability of said medical devices to the general public.

Considering that there is now adequate supply of medical devices used for the COVID-19 Pandemic, concerns regarding safety and quality of these products have grown. Hence, in order to ensure safety and quality of the medical devices used in the COVID-19 pandemic, the following guidelines are hereby adopted.

II. OBJECTIVE

To provide guidelines to the companies and institutions engaged or shall engage in importation and manufacture of PPE, ventilators and respirators to be used in the COVID-19 Pandemic.

  • GUIDELINES 

    A.  Licensing and Registration Requirements

All establishments which intend to import or manufacture PPE, ventilators and respirators to be used in the COVID-19 Pandemic are required to secure a License to Operate (LTO) as medical device importer or manufacturer, as may be proper pursuant to Administrative Order (AO) No. 2016-0003 entitled “Guidelines on Unified Licensing Requirements and Procedures of the Food and Drug Administration.”

After securing the required LTO, importers and manufacturers of PPE are advised to apply for a Certificate of Product Notification (CPN) prior commercial sale and distribution of the medical devices.

On the other hand, importers and manufacturers of ventilators and respirators are advised to apply for a Certificate of Product Registration (CPR) within three (3) months after the lifting of the State of Public Health Emergency throughout the Philippines (Proclamation No. 922 s. 2020).

The application for the CPN/CPR shall comply with the requirements of AO No. 2018-0002 entitled “Guidelines Governing the Issuance of the Authorization for a Medical Device based in ASEAN Harmonized Technical Requirements.”

Manufacturers which intend to secure product authorizations for medical devices to be used in COVID-19 shall be guided by the following standards with respect to the development, design, functionality/performance testing, product validation, risk management, sterilization, clean room environment, clinical trial (whichever is applicable), and other relevant considerations:

  1. Philippine National Standards (PNS),
  2. Applicable International Standards (ISO or IEC), in the absence of the PNS; and
  3. Technical requirements for registration as provided under AO No. 2018-0002.

Authorized importers and manufacturers of medical devices used in COVID-19 which have started to sell and distribute their products without product notification/ registration under FDA Advisory Nos. 2020-547 and 2020-449 and FDA Circular No. 2020-014 are advised to apply for a Certificate of Medical Device Notification (CMDN) or Certificate of Product Registration (CPR) within three (3) months from effectivity of this Circular. Strict post-market surveillance shall be implemented to all PPE, ventilators and respirators. Non-compliance to this requirement shall result to proper regulatory action.

Importers and manufacturers of devices that are similar in terminology but are not for medical use shall not be considered as medical devices. Such establishments need not secure a LTO or a CMDN/CPR for their products.

B. Procedure for Customs Release

For PPE, ventilators and respirators intended for entry to the local market for commercial use, the presentation of the copy of the importer’s LTO shall be sufficient compliance for customs release.

For foreign donations of the same, clearance from the FDA shall not be needed.  These include companies, other than medical device establishments with employees who use face masks in the performance of their jobs and strictly for company use.

Said procedure for clearance of PPE, ventilators and respirators prior to customs release shall be in effect until otherwise lifted.

IV. REPEALING CLAUSE

This Circular repeals FDA Advisory Nos. 2020-547 and 2020-449, and FDA Circular No 2020-014. All other issuances or parts thereof inconsistent with the provisions of this Circular are hereby repealed or modified accordingly.

V. EFFECTIVITY

This Circular shall take effect immediately and shall remain valid unless otherwise revoked, repealed or rescinded.

Attachment:-> FDA Circular No. 2020-018

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-018 || Interim Guidelines of the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators to be used in the COVID-19 Pandemic

FDA Circular No. 2020-017 || Prohibition on the Selling of Essential Emergency Medicines and Medical Devices Beyond the Price Ceiling/Range set by the Department Memorandum No. 2020-0058

Consistent with Department Memorandum No. 2020-0058 dated 31 January 2020, Department Memorandum No. 2020-0058-A dated 11 February 2020, Department Memorandum No. 2020-0058-B dated 05 March 2020, and Department Circular 2020-0186 dated 15 April 2020 issued by the Department of Health declaring the price freeze of essential emergency medicines and supplies in the entire country due to the 2019- Novel Coronavirus (Covid19), the selling of any of the following emergency medical supplies that are beyond the price ceiling/range set in the above-mentioned Department Memorandum are prohibited:

MEDICAL DEVICES PRICE
1.   Ethyl Alcohol 70% Solution 60mL 25.50
2.  Ethyl Alcohol 70% Solution 250 mL 41.75
3.  Ethyl Alcohol 70% Solution 500mL 92.00
4.  Ethyl Alcohol 70% Solution 1L 184.00
5.  Ethyl Alcohol 70% Solution 2L 368.00
6.  Ethyl Alcohol 70% Solution 3L 552.00
7.  Ethyl Alcohol 70% Solution 1 Gallon 650.00
8.  Isopropyl Alcohol 70% Solution 75mL 19.50
9.  Isopropyl Alcohol 70% Solution 150mL 36.50
10. Isopropyl Alcohol 70% Solution 250mL 42.00
11. Isopropyl Alcohol 70% Solution 330mL 82.50
12. Isopropyl Alcohol 70% Solution 500mL 99.75
13. Isopropyl Alcohol 70% Solution 1L 137.50
14. Isopropyl Alcohol 70% Solution 2L 275.00
15. Isopropyl Alcohol 70% Solution 3L 412.50
16. Isopropyl Alcohol 70% Solution 1 Gallon 520.00

We encourage the general public to check the authorization status of establishments and health products at the FDA website, www.fda.gov.ph. and also to refer with FDA Advisory No. 2020-422 “Updated List of Notified Hand Sanitizers and Registered Topical Antiseptics and Antibacterials.”

Attachment:->FDA Circular No.2020-017

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-017 || Prohibition on the Selling of Essential Emergency Medicines and Medical Devices Beyond the Price Ceiling/Range set by the Department Memorandum No. 2020-0058

FDA Circular No. 2020-016 || Prohibition of Online Selling of FDA Certified COVID- 19 Antibody Test kits

Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, and its Implementing Rules and Regulations, declares that it is the policy of the state to ensure the safety, efficacy and quality of IVD medical devices in the country so as to protect the health of the Filipino people.

The FDA issued FDA Advisory No. 2020-497 reiterating the Market Authorization Holder (MAH) of all COVID-19 antibody test kits (rapid test, point-of-care, lateral flow, Elisa, GICA, CLIA among others) with FDA special certification are strictly for medical professional use and not intended for personal use. Furthermore, FDA Advisory No 2020-498 was issued to inform the general public on purchase and administration of all FDA certified COVID-19 antibody test kits.

In view of the foregoing, all concerned stakeholders and parties are strongly reminded that online selling of FDA certified COVID-19 antibody test kits is strictly prohibited.

All FDA Regional Field Offices and Regulatory Enforcement Units are directed to conduct exhaustive monitoring of all online platforms to ensure full compliance of this Circular and to pursue and implement immediate regulatory and enforcement actions as warranted.

Attachment:-> FDA Circular No.2020-016

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-016 || Prohibition of Online Selling of FDA Certified COVID- 19 Antibody Test kits

FDA Circular No. 2020-009-B || AMENDMENT TO INCLUDE RESPIRATORY THERAPY DEVICES IN THE LIST OF MEDICAL DEVICES COVERED BY FDA CIRCULAR NO. 2020-009, AS AMENDED BY FDA CIRCULAR NO. 2020-009-A

The listing of health products enumerated under Section IV- Scope of FDA Circular No. 2020-009, as amended by FDA Circular No. 2020-009-A, entitled “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 amended to include “Respiratory Therapy Devices.”

Therefore, the listing provided under said Section of the subject Circular shall be amended to read as follows:

  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, etc.
  9. Ventilators, Respirators, their respective Accessories, and Respiratory Therapy Devices
  10. Other health products that may hereinafter identified and listed by the FDA.

This issuance shall take effect immediately.

For your information and guidance.

Attachment:->FDA Circular No.2020-009-B

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-009-B || AMENDMENT TO INCLUDE RESPIRATORY THERAPY DEVICES IN THE LIST OF MEDICAL DEVICES COVERED BY FDA CIRCULAR NO. 2020-009, AS AMENDED BY FDA CIRCULAR NO. 2020-009-A

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

I.  RATIONALE

With the implementation of the Enhanced Community Quarantine (ECQ) as a measure to control the spread of the COVID-19, certain industries were required to operate in its skeletal force or were forced to cease operations until the ECQ is lifted.

Primarily hit establishments are local drug product manufacturing industries with or without packing/repacking activity/ies and importers. Increase in demands of purchase of certain essentials medicines, particularly of vitamin drug products lead to raw material and packaging deficiencies.

To ensure continuous access of consumers to vitamins, without compromising the quality of the drug products, this Circular is hereby established.

 II.  OBJECTIVE

This Circular aims to provide guidance to the following:

  1. Guidance for initial registration of vitamin drug products of alternative packaging to its currently registered counterpart;
  2. Temporary marketing authorization of vitamin drug products with different blister or capsule color; and
  3. Temporary marketing authorization of vitamin drug products without its secondary packaging.

 III.  SCOPE AND COVERAGE

This Circular covers all locally manufactured and imported bulk registered vitamin drug products for packing/repacking under the Household Remedy (HR) and Over-the-Counter (OTC) classification.

 IV.  GUIDELINES

A.  Initial Registration

The use of a different packaging material as to the current registered packaging materials shall require an initial registration application and shall follow the complete requirements under Administrative Order (A.O.) No. 67 s. 1989 “Revised Rules and Regulations on Registration of Pharmaceutical Products”, A.O. No. 2016-008 “Revised Rules and Regulations Governing the Generic Labeling Requirements of Drug Products for Human Use”, and other relevant issuances.

Registration applications without stability data up until 12 months shall comply with the following conditions and additional requirements:

  1. Conditions:

a.  The drug product being applied for alternative packaging material must have the following:

i.  valid CPR; and
ii.  same formulation, manufacturing procedure, technical specifications and quality control tests such as assays for both raw materials and finished product.

b.  The drug product which will be approved under this Circular shall be given an interim shelf-life of 6 months with a CPR validity of only two (2) years.

c.  The drug product shall be approved under the same brand name and same entities as indicated in its reference counterpart in Section IV, A, 1, a of this Circular. A different registration number shall be given.

d.  For registered Identical Drug Products that would wish to apply an initial registration under this Circular, a Principal CPR (PCPR) counterpart must first be registered.

  1. Additional Requirements:
    1. A commitment letter to submit the stability data within one year upon the issuance of the CPR.
    2. Copy of valid Certificate of Product Registration (CPR) of its reference counterpart in Section IV, A, 1, a of this Circular.
    3. Currently approved labeling materials of the reference counterpart and proposed labeling materials of the proposed packaging materials.
    4. Actual representative sample with corresponding Certificate of Analysis.
  1. Post-Approval Compliance

The Stability Data for two (2) succeeding Commercial Batches shall be submitted within the CPR validity. Full revalidation shall be given for satisfactory stability data.

 B.  Certification of Temporary Capsule or Blister Color Use

  1. Vitamin drug products that shall use a temporary capsule or blister must secure a Certification from this Office.
  2. The following requirements shall be submitted at the FDAC Letters:
    1. Letter of Request for use of Temporary Capsule or Blister. For each proposed color or blister, a different request shall be made. Each request shall be applicable for only one drug product (hard and soft copy)
    2. Copy of valid CPR and its amendments
    3. Currently approved and proposed specifications of the capsule or blister material
    4. Pictures of the currently approved and proposed capsule or blister material, whichever is applicable.
    5. Representative samples with corresponding Certificate of Analysis
    6. Payment of Php 500.00 + LRF
  3. The certification shall be valid only until the ECQ. No further extension shall be allowed.

C.  Certification for Bundling

  1. Vitamin drug products that shall be marketed without its secondary packaging and instead thru bundling shall be required to secure a Certification from this Office.
  2. Copy of valid CPR and its amendments
  3. The following requirements shall be submitted at the FDAC Letters:
    1. Letter of Request for use of bundling.
    2. Photo of bundling (Blister or Bottle + product information leaflet)
    3. Payment of Php 500.00 + LRF
    4. Representative samples with corresponding Certificate of Analysis of the bundled product

4. The certification shall be valid only until the ECQ. No further extension shall be allowed.

D.  Application Process

  1. There shall be no need for the scheduling of submission of registration applications under this Circular. Submission shall be made in accordance with FDA Circular No. 2020-006-A “Amendment to 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”.
  2. Requests for Certifications under Sections B and C of this Circular shall be submitted at FDAC Letters.

 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 for the duration of the declared quarantine for the management of the COVID-19 situation, and the effectivity of this Circular shall likewise be automatically lifted once the imposed quarantine is lifted.

Attachment:->FDA Circular No. 2020-015

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

FDA Circular No. 2020-014 || Interim Guidelines on the Manufacture of Personal Protective Equipment (PPE), Ventilators, and Respirators in Light of COVID-19 Situation

I.  RATIONALE

The outbreak of Corona Virus Disease (COVID-19) has been declared as a pandemic by the World Health Organization and as a public health emergency by the national government. Due to this pandemic, there has been a continuous rise in the number of hospitalized patients which consequently resulted in the increase in the demand for PPE, ventilators, and respirators to manage severe cases of COVID-19.

II.  OBJECTIVE

To provide guidance to the companies and institutions signifying their interest to manufacture PPE, ventilators, and respirators to address the COVID-19 public health emergency situation, this Circular is hereby issued.

 III.  GUIDELINES

All establishments that intend to manufacture PPE, Ventilators, and Respirators are required to secure a License to Operate (LTO) as medical device manufacturer. The requirements for application of LTO are listed in Annex A of this Circular based on Section VI-A and VI-B of the Administrative Order (A.O) No. 2016-0003 entitled “Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration”. Copy  of the A.O can be downloaded at:     http://ww2.fda.gov.ph/attachments/article/303720/Administrative%20Order%20No.%202016-0003.pdf

Manufacturers who intend to continue to produce PPE, Ventilators, and Respirators for commercial use shall apply for product notification/registration within three (3) months after the lifting of the State of Public Health Emergency throughout the Philippines (Proclamation NO. 922 s. 2020) in compliance with AO No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”. For manufacturers who will only operate within the public health emergency period, no product registration/notification shall be required.

The development, design, functionality/performance testing, product validation, risk management, sterilization, clean room environment, clinical trial (whichever is applicable), and other considerations in the manufacture of these products shall be guided by the following:

  1. Philippine National Standard (PNS);
  2. Applicable Internationals Standards (ISO or IEC), in the absence of the PNS; and
  3. Technical requirements for the registration of these medical devices as stated in Administrative Order No, 2018-0002: Guidelines Governing of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements

Testing of the finished product to ensure the quality and safety shall be done by the appropriate accredited laboratory by the Philippine Accreditation Bureau.

 IV.  EFFECTIVITY

This Circular shall take effect immediately and shall remain valid unless otherwise revoked, repealed, or rescinded.

Annex A

Application Requirements and Process for LTO

 A.  Initial application

  1. Accomplished Application Form and Declaration and Undertaking
  2. Proof Business Name Registration
  3. Site Master File (for manufacturers of drugs, devices, and cosmetics)
  4. Risk Management Plan
  5. Payment

B.  Application Process

  1. Filing
  2. Evaluation
  3. Inspection

Pre-opening inspection shall be mandatory for manufacturers. All covered establishments may be inspected at any time by FDA as part of its post-marketing surveillance activities.

 Guidance for the above requirements can be seen on Administrative Order 2016-0003

Attachment:->FDA Circular No.2020-014

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-014 || Interim Guidelines on the Manufacture of Personal Protective Equipment (PPE), Ventilators, and Respirators in Light of COVID-19 Situation

Joint Memorandum Circular No. 01 Series Of 2020 || CREATION OF BAYANIHAN ONE STOP SHOP FOR SECURING LICENSE TO OPERATE (LTO) TO IMPORT COVID-19 CRITICAL COMMODITIES FOR COMMERCIAL DISTRIBUTION

I.  BACKGROUND

The declaration of a State of Calamity by President Rodrigo Duterte through Presidential Proclamation 929 on March 16, 2020 and the imposition of an Enhanced Community Quarantine (ECQ) in Luzon as a consequence of the spread of the Corona Virus Disease (“COVI D-19”), resulted to a lot of streamlining efforts by various government agencies in procedures involving critical government services. These efforts were initiated as the need to reduce and/or avoid person-to-person contact in processing necessary permits and authorizations have become increasingly necessary , including those intended for the importation of Personal Protective Equipment (“PPE”) and specific medical devices essential for the management of (“COVID-19 Critical Commodities”).

Despite the streamlining efforts of concerned government agencies, bottlenecks and challenges in the importation process remain. This is particularly true with respect to commercial importations of COVID-19 Critical Commodities. Among these are the following:

  • confusion and misinformation of the public on procedures for commercial importations of COVID-19 Critical Commodities by private entities; and
  • continued operation of government agencies under a “silo system” where applicants need to transact with individual government agencies separately, even if they are part of the entire importation process.’

Needless to say, even if each agency involved in the importation process streamline its procedures and reduce documentary requirements, applicants still deal with the government on a “piece-meal” basis. This means that any delay or challenge in one government agency produces a domino effect across the other import processing agencies, which becomes unduly burdensome to the importer.

There is, thus, an increasing public clamor and need for more efficient inter-connected processes, particularly in the commercial importation of COVID19 Critical Commodities. For emphasis, this does not cover the clearance of relief consignments entered during a state of calamity which is already covered by Joint Administrative Order No. 1-2020.2

II.  PURPOSE

The creation of Bayanihan One Stop Shop (BOSS) is hereby adopted through the joint efforts of the Bureau of Customs (BOC), Food and Drug Administration (FDA), and Anti-Red Tape Authority (ARTA) pursuant to the relevant provisions of Republic Act No. 11469 or the “Bayanihan to Heal as One Act” (the “Bayanihan Act”). Section 4 of the Bayanihan Act grants the President the power to adopt certain temporary emergency measures to respond to the crisis brought by the COVID-19 pandemic, including among others, the following:

  1. To continue to enforce measures to protect the people from xxx other pernicious practices affecting the supply, distribution and movement of xxx sanitation products, medicine and medical supplies, and other articles of prime necessity, whether imported or locally produced or manufactured (Section 4 (i));

  2. To ensure that donation, acceptance and distribution of health products intended to address the COVID-19 public health emergency are not unnecessarily delayed and that health products for donation duly certified by the regulatory agency or their accredited third party from countries with established regulation shall automatically be cleared: Provided, That this shall not apply to health products which do not require a certification or clearance from Food and Drug Administration (FDA) (Section 4(j)); and
  3. To liberalize the grant of incentives for the manufacture or importation of critical or needed equipment or supplies for the carrying-out of the policy declared herein, including healthcare equipment and supplies: Provided, That importation of these equipment and supplies shall be exempt from import duties, taxes and other fees (Section 4 (0)). [Emphasis supplied]

to continue reading, click the attachment below…

Attachment:-> Joint Memorandum Circular No. 01 Series Of 2020 (BOC-ARTA-FDA)

/ In Circular / By Administrator / Comments Off on Joint Memorandum Circular No. 01 Series Of 2020 || CREATION OF BAYANIHAN ONE STOP SHOP FOR SECURING LICENSE TO OPERATE (LTO) TO IMPORT COVID-19 CRITICAL COMMODITIES FOR COMMERCIAL DISTRIBUTION

FDA Circular No. 2020-013 || Guidelines for Monitoring Drug Products Used for the Treatment of COVID-19

I.  INTRODUCTION

The coronavirus disease (COVID-19) outbreak has been declared a pandemic. Enhanced Community Quarantine (ECQ) was declared and a state of Public Health Emergency throughout the Philippines is in effect. Undeniably, the country is in the midst of an emergency brought about by COVID-19 posing a clear and present risk to the health and lives of the general public. A global search for an effective treatment is on the race to save the lives of infected people against this emerging disease. Drug products opted to be used in this emergency crisis must be of good quality and its safety is monitored.

II.  OBJECTIVE

This Circular aim to provide interim guidelines on the (1) reporting of adverse drug reactions (ADR) on the medicines used for the treatment of COVID-19 and (2) quality monitoring of these drug products.

III.  SCOPE

This Circular applies to all Marketing Authorization Holders (MAHs), in coordination with hospitals and other health facilities, of the following drug products that will be used for the treatment of patients with COVID-19:

  • Chloroquine (CQ)
  • Hydroxychloroquine (HCQ)
  • Lopinavir + Ritonavir
  • Tocilizumab
  • Other drug product/s that will either be used as a monotherapy or in combination with any of the mentioned drug product for an effective treatment of COVID-19

IV.  GUIDELINES

A.  For Hospitals, other Health Facilities, and Healthcare Professionals

  1. All government and private hospitals, and other health facilities including healthcare professionals shall monitor the safety of the drug products used for the treatment of COVID-19 patients.
  2. ADR reports shall be coordinated and submitted to the respective suppliers/MAH who will be responsible in submitting these reports to the FDA.
  3. If the products were donated with no local MAH and supplied by the Department of Health (DOH), ADR reports shall be directly submitted to the FDA through any of the following:

 B.  For Marketing Authorization Holders

  1. Adverse Drug Reaction Reporting
  1. All provisions of the FDA Circular No. 2020-003: Guidelines for Pharmaceutical Industry on Pharmacovigilance shall be followed including those specified in this Interim Guidelines.
  2. All ADRs whether serious, non-serious, expected, or unexpected which are experienced by the patients receiving any of the above-mentioned drug products as off-label use for the treatment of COVID-19 must be reported to the FDA.
  3. All ADR reports must be treated as solicited reports and there must be an organized data collection system in coordination with hospitals and other health facilities using their products in treating patients with COVID-19.
  4. Discharged patients treated and prescribed with take home medicines of the aforementioned drug products shall be followed up for any side effects or ADR.
  5. Any outcome on the use of these drug products during pregnancy shall be monitored in reference to the FDA Circular No. 2020-003.
  6. All ADRs must be notified to the FDA on a daily basis, updated in the line-listing, and must be sent through email to [email protected]. Each drug product should have a separate line-listing and must have at least the following information:
  • Date of receipt of information
  • Age
  • Sex
  • Suspected adverse reaction (MedDRA)
  • Date of onset of reaction
  • Seriousness (non-serious or serious [criteria])
  • Indicate if no ADR report was received on a particular date.

g. All notified ADRs must be completed and reported to the FDA as soon as possible, regardless of its seriousness and expectedness, but not later than fifteen (15) calendar days. The reporting time clock starts after the first knowledge of any personnel of the MAH on the said adverse reaction. Indicate in the Individual Case Safety Report that the drug was used for the treatment of COVID-19 [for E2B, use “coronavirus infection” as MedDRA term in elementIndication(s) for use then indicate “COVID-19” in the element Case narrative; for CIOMS Form I indicate “COVID-19” directly in 17. Indication(s) for use].

  1. Product Quality Monitoring for MAH
  1. Distribution records of each drug product must be submitted by the MAH to the FDA with the following conditions for monitoring and traceability, especially when untoward events or situations arise:
  1. Submission of these records must be made from the start of distribution to the market and must be updated weekly, every Thursday.
  2. These must be sent to [email protected] with the subject: Distribution Records [COVID19]-[Registration No.], e.g., Distribution Records [COVID19]-DR-XYxxxxx.
  3. The records must start with the total quantity of stocks manufactured or imported. Thereafter, distributed stocks must be deducted from this total quantity.
  4. The said records must be provided in an .xlsx or .xlsm file format (Microsoft Excel) with the following format for consistency:
REG. NO. TOTAL QTY. (manufactured or imported) BATCH/ LOT NO. MFG. DATE EXP. DATE NAME OF RECIPIENT ESTABLISHMENT CLASSIFICATION

(Distributor, Community Drugstore, Hospital, Other Health Facility)

QTY. DISTRIBUTED REMAINING STOCKS

v. In another worksheet in your Excel workbook, list down all of the names of recipient establishments with the following format for consistency:

NAME OF RECIPIENT ESTABLISHMENT COMPLETE ADDRESS CONTACT PERSON DESIGNATION OF CONTACT PERSON TEL. NO. MOBILE NO. E-MAIL ADDRESS

b.  The MAH shall implement their extensive post-marketing surveillance for the abovementioned drug products. Verified counterfeits of these shall be immediately reported to the FDA by sending an e-mail to [email protected] as an advance notification and shall submit the actual sample thereafter at the FDA Action Center. This shall form as part of the Risk Management Plan for establishment of the MAH.

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 Order shall take effect immediately and deemed valid until further notice.

Attachment:->FDA Circular No.2020-013

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-013 || Guidelines for Monitoring Drug Products Used for the Treatment of COVID-19

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

  1. I. RATIONALE

    The coronavirus disease (COVID-19) outbreak has been declared a pandemic. Enhanced Community Quarantine (ECQ) was declared and a state of Public Health Emergency throughout the Philippines is in effect. Undeniably, the country is in the midst of an emergency brought about by COVID-19 posing a clear and present risk to the health and lives of the general public. A global search for an effective treatment is on the race to save the lives of infected people against this emerging disease. In the management algorithm issued by the Philippine Society for Microbiology and Infectious Diseases (PSMID) for the Clinical Management of Adult Patients with Suspected or Confirmed COVID-19 Infection, as adopted by the Department of Health thru Department Memorandum No. 2020-0138, certain drug products are considered for use in hospitalized, probable or considered patients with COVID-19. There is an emergent need to address the public’s need for quality, safe, and effective medicines for the disease.

    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:

    Generic Name Dosage Form and Strength
    Tocilizumab 400 mg/ 20 mL Concentrate Solution for I.V. Infusion
    Lopinavir + Ritonavir 200 mg/ 50 mg Film-Coated Tablet
    Chloroquine Phosphate 250 mg Tablet

    500 mg Tablet

    Hydroxychloroquine Sulfate 200 mg Film-Coated Tablet

    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
      • Generic Labeling Exemption may be granted for products exceeding 12,000 units.
    8. Product Composition/Formulation (Unit Dose and Batch Formulation)
    9. Finished Product Technical Specifications
    10. Finished Product Certificate of Analysis (CoA) and Batch Analysis
    11. Stability Studies
      • Drug products with no stability studies shall be given an interim shelf-life of 6 months.
    12. Proof of Payment (Official Receipt or Landbank Oncoll Payment Slip)

    C. Application Process

    1. There shall be no need for the scheduling of submission of applications under this Circular.
    2. 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 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:
      1. Post-Approval Stability Data of Commercial Batch/es for products without stability data submitted upon its registration
      2. Commercial sample from the first batch of manufacture (local) or importation shall be submitted to this Office prior to distribution
      3. Reference standards of the Active Pharmaceutical Ingredient/s (API) – submission shall be within five (5) working days from the CPR issuance
    1. 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 for the duration of the declared quarantine for the management of the COVID-19 situation, and the effectivity of this Circular shall likewise be automatically lifted once the imposed quarantine is lifted.

Attachment:->FDA Circular No.2020-012

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

FDA Circular No. 2020-006-A || AMENDMENT TO 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

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 as the Agency’s response to the Community Quarantine declaration.

The subsequent declaration of an Enhanced Community Quarantine (ECQ) prompted Local Government Units to impose lockdowns, including the proclamation of the City of Muntinlupa to place the city under twenty-four (24) hour curfew through Muntinlupa City Ordinance No. 2020-074. As a result, work from home scheme will be strictly implemented by the FDA to ensure continuity of government service during the period of Covid-19 outbreak to prevent further spread of the disease. Thus, modification and adjustment in the existing systems and procedures in the application for authorization is in order and hereby adopted.

This issuance aims to provide supplemental guidance relative to the interim changes in FDA’s work arrangement.

Read more:->FDA Circular No.2020-006-A

Related Circular:-> FDA Circular No. 2020-006

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-006-A || AMENDMENT TO 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

FDA Circular No. 2020-009-A || AMENDMENT TO INCLUDE VENTILATORS,RESPIRATORS AND THEIR RESPECTIVE ACCESSORIES TO THE LIST OF MEDICAL DEVICES COVERED BY FDA CIRCULAR NO. 2020-009

The listing of health products enumerated under Section IV- Scope of FDA Circular No. 2020­-009, or 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 amended to include ventilators, respirators and their respective accessories.

Hence, the listing provided under said Section of the subject Circular shall be amended to read as follows:

  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, etc.,
  9. Ventilators, Respirators and their respective Accessories, and
  10. Other health products that may hereinafter be identified and listed by the FDA.

This Order shall take effect immediately.

For your information and guidance.

Attachment:-> FDA Circular No.2020-009-A

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-009-A || AMENDMENT TO INCLUDE VENTILATORS,RESPIRATORS AND THEIR RESPECTIVE ACCESSORIES TO THE LIST OF MEDICAL DEVICES COVERED BY FDA CIRCULAR NO. 2020-009

FDA Circular No. 2020-011 || GUIDELINES ON PHARMACY COMPOUNDING OF ALCOHOL-BASED HAND SANITIZER FORMULATIONS IN LIGHT OF THE DECLARATION OF STATE OF CALAMITY DUE TO COVID-19

This Circular aims to provide guidelines that will enable licensed drug retail outlets to perform compounding of alcohol-based hand sanitizers of acceptable quality, safety, and efficacy for consumer and health care personnel use.

to continue reading, click the attachment below…

Attachment:-> FDA Circular No.2020-011

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-011 || GUIDELINES ON PHARMACY COMPOUNDING OF ALCOHOL-BASED HAND SANITIZER FORMULATIONS IN LIGHT OF THE DECLARATION OF STATE OF CALAMITY DUE TO COVID-19

FDA Circular No. 2020-010 || Prohibition of Online Selling of Unregistered/Unnotified Medical Devices

Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, specifically prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products (including medical devices and supplies) without the proper authorization.

Likewise, the DTI-DOH-DA Joint Administrative Order No. 01 series of 2008 entitled “Rules and Regulations for Consumer Protection in a Transaction Covered by the Consumer Act of the Philippines (R.A. 7394) Through Electronic Means Under the E-Commerce Act (R.A. 8792)” mandatorily requires that all retailers, sellers, distributors, suppliers or manufacturers engaged in electronic commerce with consumers must ensure compliance with the requirements for safe and good quality of devices under Title II of the R.A. 7394.

Therefore, all concerned establishments are strongly reminded that online selling of medical devices and supplies without the corresponding authorizations issued by the FDA (i.e. License to Operate, Certificate of Medical Device Notification or Certificate of Medical Device Registration/Certificate of Product Registration) is strictly prohibited.

Also, the public is advised not to purchase any unregistered or violative medical devices and supplies sold or offered for sale through online platforms.

All FDA Regional Field Offices and Regulatory Enforcement Units are directed to conduct exhaustive monitoring of all online platforms to ensure full compliance of this circular and to pursue and implement immediate regulatory and enforcement actions as warranted.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected].

To report any sale or distribution of unregistered medical device, email us at [email protected]

For your guidance and strict compliance.

Attachment:-> FDA Circular No.2020-010

FDA Circular No. 2020-005-A || Amendment to FDA Circular No, 2020-005 re: Prohibition on the Online Selling of Essential Emergency Medical Supplies Beyond the Price Ceiling/Range set by Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-A

In line with the issuance and implementation of Department Memorandum No. 2020­-0058-B dated 5 March 2020 re: Further Amendment to Department Memorandum (DM) No. 2020-0058 dated January 31, 2020 and DM No. 2020-0058-A dated February 11, 2020 entitled “Price Freeze of Essential Emergency Medicines Due to the 2019-Novel Coronavirus (2019-nCov) Health Event”, FDA Circular No. 2020-005 is hereby amended to include the following products in the list of essential medical devices/supplies with prescribed price ceiling/range:

ESSENTIAL MEDICAL
DEVICES/SUPPLIES

LOWEST
(Php)

HIGHEST
(Php)

1. Sterile gloves per pair (Size 6.5, 7, 7.5, 8) 18.00 21.00
2. Safety goggles 30.00 55.00

All other provisions of FDA Circular No. 2020-005 not affected by the amendment shall remain valid and effective.

Attachment:-> FDA Circular No.2020-005-A

Related Article:-> http://bit.ly/3aZFIQj

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-005-A || Amendment to FDA Circular No, 2020-005 re: Prohibition on the Online Selling of Essential Emergency Medical Supplies Beyond the Price Ceiling/Range set by Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-A

FDA Memorandum Circular No. 2020-001 || 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

This Memorandum is being issued to provide FDA’s interim regulatory guidelines to all manufacturers seeking to temporarily produce rubbing alcohol, in light of the current increase in demand due to the COVID-19 pandemic, for the issuance of a License to Operate (LTO) and Certificate of product notification (CPN).

Read more:-> FDA Memorandum Circular No. 2020-001
Attachment:-> Annex A

/ In Circular / By Administrator / Comments Off on FDA Memorandum Circular No. 2020-001 || 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

FDA Circular No. 2020-009 || 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

The Corona Virus Disease (COVID-19) outbreak has been declared as a pandemic.  A State of Public Health Emergency throughout the Philippines is in effect, and enhanced Community Quarantine was declared.  Undeniably, the country is in the midst of a emergency brought about by the COVID-19 disease posing a clear and present danger to the health and lives of the public.

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]

 ___________________________

[1] “Guidelines on the Acceptance and Processing of Foreign and Local Donations During Emergency and Disaster Situations”

[1] “Mandatory Reporting of Notifiable Diseases and Health Events of Public Health Concern Act”

[1]Philippine Disaster Risk Reduction and Management Act of 2010

 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, etc., and
  9. 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. Effectivity

This Order shall take effect immediately and shall be in effect until 30 May 2020 unless sooner revoked or extended.

For your information and guidance.

Attachment:-> FDA Circular No. 2020-009

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-009 || 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. 2020-008 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted During the 31st ASEAN Cosmetic Committee (ACC) Meeting and Its Related Meetings

Read more:-> FDA Circular No. 2020-008
Attachment:-> FDA Circular No. 2020-008 Annex A

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-008 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted During the 31st ASEAN Cosmetic Committee (ACC) Meeting and Its Related Meetings

FDA Circular No. 2020-007 || GUIDELINES IN THE IMPLEMENTATION OF THE USE OF ELECTRONIC MEANS OF PRESCRIPTION FOR DRUGS FOR THE BENEFIT OF INDIVIDUALS VULNERABLE TO COVID-19

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.

READ MORE–>FDA Circular No. 2020-007

Para sa karagdagang impormasyon  sa Circular No. 2020-007, narito ang pahayag ng FDA patungkol dito. BASAHIN —> http://bit.ly/33tbTEQ

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-007 || 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. 2020-005 || Prohibition on the Online Selling of Essential Emergency Medical Supplies Beyond the Price Ceiling/Range set by Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-A

Consistent with Department Memorandum No. 2020-0058 dated 31 January 2020 and Department Memorandum No. 2020-0058-A dated 11 February 2020 issued by the Department of Health declaring the price freeze of essential emergency medicines and supplies in the entire country due to the 2019- Novel Coronavirus (Covid19), the online selling of any of the following emergency medical supplies that are beyond the price ceiling/range set in the above-mentioned Department Memorandum are prohibited:

ESSENTIAL MEDICAL DEVICES LOWEST
(Php)
HIGHEST
(Php)
1.  Particulate respirator, Grade N95 45.00 105.00
2. Disposable face mask (Medical mask for health workers and patients) 3.00 12.00
3.  Ethyl alcohol 70% solution 60 mL 17.25 25.50
4.  Ethyl alcohol 70% solution 250 mL 36.75 41.75
5.  Ethyl alcohol 70% solution 500 mL 61.00 74.25
7.  Sterile gloves 25 pairs/box (Size 6.5, 7, 7.5,8) 295.00 450.00
8.    Nebulizer 1,495.00 3,980.00
9.    Neb kit: adult 87.00 120.00
10.  Neb kit: pedia 63.00 142.00
11.  Oxygen cannula: adult 24.00 60.00
12.  Oxygen cannula: pedia 18.50 53.00
13.  Oxygen cannula; neonatal 24.00 50.00

All FDA Inspectors and Regulatory Enforcement Unit agents are directed to conduct exhaustive monitoring of all online platforms to ensure full compliance of this Circular and the above-mentioned DOH issuances and to pursue and implement immediate regulatory and enforcement actions as warranted.

This Circular shall take effect immediately and shall remain valid unless otherwise revoked, repealed or rescinded.

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-005 || Prohibition on the Online Selling of Essential Emergency Medical Supplies Beyond the Price Ceiling/Range set by Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-A

FDA Circular No. 2020-004 || Prohibition of Selling of COVID-19 Testing Kit without Authorization from FDA

In view of the ongoing concern on the spread of coronavirus disease (COVID-19) which has placed the country under state of public health emergency, all healthcare professionals, stakeholders and the general public are hereby advised not to distribute, sell or use COVID-­19 Testing Kit without authorization from the Food and Drug Administration (FDA). This is to ensure the provision of accurate and reliable information regarding result of the COVID­-19 test to be conducted.

All concerned establishments are warned not to distribute, advertise, or sell COVID-19 testing kit until a corresponding authorization has been issued by FDA; otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that only COVID-­19 testing kit with FDA authorization is sold or made available in the market or their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of COVID-19 testing kit without FDA authorization.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected]or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unauthorized medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Circular No.2020-004

FDA CIRCULAR NO. 2020-001 || Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements”

to continue reading, click the attachment below…

Attachment:-> FDA CIRCULAR NO.2020-001

/ In Circular / By Administrator / Comments Off on FDA CIRCULAR NO. 2020-001 || Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements”
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