Philippines FDA issues second update to license application guidelines during Covid-19
The Philippines Food and Drug Administration (FDA) has issued a second amendment to its guidelines on FDA-issued authorizations due to the ongoing global pandemic and community quarantine requirements.
FDA Circular 2020-024 entitled “Updated guidelines for applications of authorizations with the FDA in light of community quarantine declarations” was first issued on 20 August 2020. It was first amended through the issuance of FDA Circular 2020-024A on 18 February 2021 to grant extension periods for those product licenses and certificates which were due to expire between 01 January 2021 and 30 June 2021.
However, in light of the continuing global pandemic the FDA has decided to grant further extensions for certain authorizations that are due to expire between 01 July 2021 and 31 December 2021. The newly issued FDA Circular 2020-024B takes effect immediately (as of 22nd July 2021). The extensions apply to:
- Licenses To Operate (LTO),
- Certificates of Product Registrations (CPR) and Certificates of Product Notifications (CPN),
- Local Good Manufacturing Procedure (GMP) Certificates,
- Certificate of Compliance (COC) for X-ray facilities under the One-Stop Shop licensing system of the Department of Health
- Certificate of Registration (COR) for Magnetic Resonance Imaging (MRI) facilities.
The above authorizations have been granted an automatic extension of 4 (four) months provided that a renewal application is filed with the FDA during the extension period. Failure to file the renewal application during this time will render the authorizations expired. However, renewal applications submitted within 120 days of the extended expiry date will be subject to surcharges in addition to the normal application fees.
This 4-month extension is non-cumulative and will only be granted once to existing authorizations. Licensed establishments are advised to attach the following in all transactions with the Bureau of Customs. This will support the ongoing authorization and importation of medical devices which expire during the four-month extension period:
- FDA Circular 2020-024
- FDA Circular 2020-024A
- FDA Circular 2020-024B
- Acknowledgement Receipt
- Official Receipt of the renewal application.
Typical fees for Medical Device and IVD renewals in the Philippines
Class | Fee (inclusive of 1% Legal Research Fund fee) | Timeline |
Class A | PHP 5,050 (~US$105) | 1-2 months |
Class B, C and D | PHP 5,050 (~US$105) | 3-6 months |
IVD | PHP 5,050* (~US$105) | 3-6 months** |
* Does not include the cost for performance evaluation test. Cost of testing depends on the corresponding National Reference Laboratory (NRL)
** Not including performance evaluation test by NRL (National reference Laboratory)
More information:
Click here for FDA Circular 2020-024B from the Philippines FDA on these regulatory flexibilities.
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