Title/Subject:

1.  Coronavirus disease (COVID-19) advice for the public: Mythbusters (IEC)

1. Alcohol
2. Antibiotics
3. Bleach
4. Drugs
5. Hydroxychloroquine
6. Masks, CO2 Intoxication – Video
7. Masks, Exercise
8. Medicines
9. Methanol, Ethanol
10. Pneumonia Vaccines
11. Thermal Scanners
12. Viruses, Bacteria, Antibiotics

2.  Q&As on COVID-19 and Related Health Topics
3.  Coronavirus disease (COVID-19) advice for the public: When and how to use masks

1. How to Wear a Medical Mask Safely – Do’s
2. How to Wear a Medical Mask Safely – Don’ts
3. How to Wear a Medical Mask – Video

To date, FDA has released a total of 204 COVID – 19 Test Kits (71 – PCR based, 77 – Rapid Antibody, 51 – Immunoassay and 5 – Others)

Click the link below for details.

https://bit.ly/2Zd0CZ4

The Food and Drug Administration (FDA) – Policy and Planning Service-Information and Communication Technology Management Division (PPS-ICTMD) will conduct a system maintenance starting on 03 July 2020 at 5:00 PM until 06 July 2020.

With this, we regret to inform you that the following Systems will be temporarily unavailable:

1. ePortal
2. FDA Website
3. FIS

The aforecited system applications will be restored by 06 July 2020 at 7:00 AM for regular business operations.

Thank you.

Attachment:->System Maintenance from 03 to 06 July 2020

All comments shall be forwarded to [email protected]. no later until 10 July 2020.

OBJECTIVES

The general objective of this Circular is to provide a clear and consistent procedure for the safety of FDA employees and clients in order to prevent the spread of infectious diseases such as COVID-19 in the workplace.

Specifically, it aims to:
2.1 Limit foot traffic;
2.2 Limit face to face interaction by encouraging online transactions.

to continue reading, click the attachment below…

Attachment:->Draft for Comments New Normal Operational Guidelines of FDA at the FDAC

Pursuant to the declaration of the State of Public Health Emergency due to COVID-19 pandemic, all are directed to observe and comply with the quarantine protocols and preventive measures against this disease.

In relation to this, we would like to advise the academe that the Food and Drug Administration will temporarily suspend its Internship Program and will not be accommodating requests for Educational Tour until further notice. This is to ensure the safety and health of the students.

For information and guidance. Thank you very much.

Attachment:-> Announcement – July 02 2020

This is in reference to the Memorandum on the pre-assessment and acceptance of applications for Lot Release Certification (LRC) dated 10 June 2020. Please be guided with the changes in schedule and inclusion of other types of applications as follows:

The online submission and the changes in schedule shall be available and in effect until further notice. This memorandum supersedes the one mentioned above, which can be viewed at https://www.fda.gov.ph/pre-assessment-and-acceptance-of-applications-for-lot-release-certification/. These changes shall also be incorporated in the soon to be released FDA Circular for the New Normal Operational Guidelines at FDAC.

For any inquiries or concerns, please do not hesitate to contact us through email or call us at +632 8 8571900 loc. 1261.

For your information and guidance.

Attachment:->Memorandum for Lot Release Certification

Please be advised that the Opening of Bids for the above mentioned project as scheduled on 19 June 2020 at 9:30AM respectively, will be postponed due to the absence of quorum.

For information and guidance of all concerned.

Attachment:->Postponement of Opening of Bids for ITB No. 2020-001-AFS

In the consideration of the gaps in the delivery of services due to the current restrictions brought about by the government’s response to Covid-19 pandemic, please be advised that an additional mode for the acceptance of applications for lot release pre-assessment has been made available. Applications may be submitted to the Common Services Laboratory – Vaccine and Biological Unit (CSL-VBU) for pre-assessment by email to [email protected].

Emails shall be separate for each product lot/batch. All requirements (except for the actual representative samples for retention) shall be submitted in PDF format and as separate files. This service shall be available from Mondays to Fridays from 8:00 AM to 5:00 PM. Applications submitted outside of said schedule shall be pre-assessed upon the resume of schedule. An email will be sent to the applicant shortly after the pre-assessment. This may be a clarification (as needed) or acceptance (if complete and satisfactory).

The email of acceptance shall be printed and included in the documents to be submitted in hard copy at the FDA Action Center (FDAC) CSL counter. Acceptance of the application documents and samples for retention shall be from Mondays to Fridays from 9:00 AM to 3:00 PM.

However, for applicants who are unable to avail of this online pre-assessment service, they may still submit applications directly at FDAC CSL Counter on Mondays AND Fridays only from 9:00 AM to 3:00 PM, subject to pre-assessment prior to acceptance.

This mode of application shall be available until further notice. For any inquiries or concerns, please do not hesitate to contact us through email or call us at +632 8 8571900 loc. 1261.

For your information.

Attachment:-> Pre-assessment and Acceptance of Applications for Lot Release Certification

The Food and Drug Administration (FDA) – Policy and Planning Service-Information and Communication Technology Management Division (PPS-ICTMD) will conduct a system maintenance starting on 12 June 2020 at 8:00 AM until 14 June 2020.

          With this, we regret to inform you that the following Systems will be temporarily unavailable:

1. ePortal
2. FDA Website
3. FIS

          The aforecited system applications will be restored by 15 June 2020 at 6:00 AM for regular business operations.

Attachment:-> SYSTEM MAINTENANCE ON 12 June 2020 to 14 June 2020

To provide ample time for the transfer of the Food and Drug Action Center (FDAC) back to Starmall Alabang on 15 June 2020, Monday, office work at FDAC will be suspended from 12:00 noon onwards on 11 June 2020, this Thursday.

Applicants with confirmed schedule to appear on the said date will be accommodated during regular office hours.

For further inquiries, you may ring the following mobile numbers.

Email: [email protected].

Please be guided accordingly. Thank you.

Attachment:-> Half-Day Work Suspension at the (FDAC) on 11 June 2020

Please be informed, that the CDRR is soliciting for comments from the concerned stakeholders on the draft FDA Circular entitled:  Interim Guidelines for the Issuance of Current Good Manufacturing Practice (cGMP) Clearance to Foreign Drug Manufacturers

Comments may be submitted by email to: [email protected] not later than 10 June 2020 (Wednesday) at 3:00PM using the following format:

In sending your comments, please use the subject: [Comments] Interim Guidelines for FcGMP Clearance

Thank you.

Attachment:->Announcement Interim Guidelines for the Issuance of Foreign cGMP Clearance

Attachment:->Draft on Interim Guidelines for the Issuance of Foreign cGMP Clearance

Please be advised that starting tomorrow, 04 June 2020 until Monday, 15 June 2020, our FDAC Landline numbers will be temporarily disabled in preparation to the upgrade of our telephone system.

In the meantime, you may reach us thru the following contact numbers:

Mobile:

GLOBE/TM:

• 0956-4518268
• 0956-4518341
• 0953-1609550
• 0935-4859583
• 0977-6177991
• 0977-6177994

SMART:

• 0961-6804447
• 0951-1311186
• 0961-0574926
• 0961-0574927

Email: [email protected]

Operating hours from 9AM to 4PM during working days. Rest assured that our team will respond to your concerns as soon as we can.

Thank you.

Attachment:->UPDATED CUSTOMER MOBILE HOTLINES OF FDAC

Please be informed that FDA Regional Field Office IV-B (RFO IV-B) MiMaRoPa has transferred to its new office from 3^rd Floor Halcon Heights Building, Dama de Noche St. cor. Roxas Drive, Lumangbayan, Calapan City, Oriental Mindoro to Unit 13, Filipiniana Complex, Sto. Niño, Calapan City, Oriental Mindoro.

Kindly contact the following for queries:

For your information and guidance.

Thank you very much.

Attachment:-> ANNOUNCEMENT-TRANSFER OF OFFICE OF THE FDA RFO-IV-MIMAROPA

UPDATE as of 5PM: FDA approved 11 additional kits (5 PCR, 6 SEROLOGIC) as of 02 June 2020. Total registered COVID-19 Test Kits for commercial use is now 132.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

UPDATE as of 5PM:  FDA approved 17 additional kits (1 PCR, 16 SEROLOGIC) as of 27 May 2020. Total registered COVID-19 Test Kits for commercial use is now 121.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

UPDATE as of 5PM: FDA approved 11 additional kits (4 PCR, 7 SEROLOGIC) as of 22 May 2020. Total registered COVID-19 Test Kits for commercial use is now 104.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

This Administrative Order aims to achieve the following:

1. Ensure the full protection of the rights and safety of human subjects and the integrity of clinical trial data through the adoption and implementation of International Council of Harmonization-Good Clinical Practice (ICH GCP) standards;
2. Ensure efficient and effective process for the approval of clinical trials;
3. Provide standards and requirements for the regulation and importation of Investigational Products; and
4. Strengthen the monitoring of compliance of all organizations, institutions and entities to GCP and other related FDA regulations through regulatory inspections.

Read more:->Administrative Order 2020-0010

The objectives for issuing this Administrative Order are as follows:

1. To simplify the requirements and processes for initial, renewal, and variation of License to Operate (LTO) applications; and
2. To re-engineer and streamline FDA’s processes and automate its system in compliance with the provisions of RA 11032 in the maximum prescribed processing time depending on the complexity of the transaction.

Read more:->Administrative Order No.2020-0017

UPDATE as of 5PM:  FDA approved 7 additional kits (2 PCR, 5 SEROLOGIC) as of 19 May 2020. Total registered COVID-19 Test Kits for commercial use is now 93.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

To our valued clients and stakeholders, to further improve our service and cater to more clients, we have now a total of (6) six mobile numbers:

Mobile no.:

GLOBE:

0956-4518268

0956-4518341

0953-1609550

0935-4859583

SMART:

0961-6804447

0951-1311186

Other active communication lines:

Phone: 02 8821 1176, 02 8821 1177 and 02 8821 1220

Email: [email protected]

Operating hours from 9:00am to 4:00pm

Rest assured that our team will respond to your concerns as soon as we can.

UPDATE as of 5PM:  FDA approved 4 additional SEROLOGIC test kits as of 15 May 2020. Total registered COVID-19 Test Kits for commercial use is now 86.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

This is to notify all concerned stakeholders and the general public that the Draft FDA Circular entitled “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” is now posted in the FDA Website for public comments.

Kindly send your comments through email at [email protected] on or before 29 May 2020.

 For your information and guidance.

Attachment:-> Guidelines for the E-Licensing of PCOs – for Public Comments

UPDATE as of 4PM:  FDA approved 2 additional SEROLOGIC test kits as of 14 May 2020. Total registered COVID-19 Test Kits for commercial use is now 82.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

UPDATE as of 5PM:  FDA approved 3 additional kits (1 PCR, 2 SEROLOGIC) as of 11 May 2020. Total registered COVID-19 Test Kits for commercial use is now 80.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

To our valued clients and stakeholders, to further improve our service and cater to more clients, we have included additional customer hotlines below:

Mobile no.:

GLOBE: 0956-4518268
              0956-4518341

SMART: 0961-6804447
               0951-1311186

Other active communication lines:

Phone: 02 8821 1176, 02 8821 1177 and 02 8821 1220

Email: [email protected] 

Rest assured that our team will respond to your concerns as soon as we can.

UPDATE as of 4PM: FDA approved 2 additional RAPID test kits today 08 May 2020. Total registered COVID-19 Test Kits for commercial use is now 77.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

UPDATE as of 4PM:  FDA approved 5 additional kits (1 PCR, 4 RAPID) as of 05 May 2020. Total registered COVID-19 Test Kits for commercial use is now 75.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

UPDATE as of 5PM:  FDA approved 11 additional kits (3 PCR, 8 RAPID) as of 04 May 2020. Total registered COVID-19 Test Kits for commercial use is now 70.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

Click the link below for details.

Updated List as of 29 April 2020 

See also ->>  FDA Advisory No.2020-422