Philippines FDA medical device authorizations during state of emergency
The Philippines FDA issued Circular no. 2021-025 listing the latest guidelines for the application of FDA authorizations in light of the extended state of public health emergency.
The extended state of emergency came into effect on 13 September 2021 by Proclamation no. 1218 and will last until 12 September 2022 unless lifted earlier or extended further.
Last year, the FDA had already issued Circular no. 2020-024 and further amendments granting extended validity of certain FDA authorizations that were due to expire on 01 January 2021. However, in light of the continuing impact of Covid-19 in the Philippines, the FDA has issued these new guidelines, Cirular no. 2021-025, which aim to strengthen previously issued guidelines and to guarantee the continuity of services.
This FDA circular applies to all concerned parties applying for FDA authorizations and other stakeholders who are required to submit documents, appear at the FDA for compliance/meetings, and/or pay appropriate fees or charges covered by this FDA Circular. The FDA-issued authorizations include but are not limited to the following:
- Licenses to Operate
- Certificates of Product Registrations (CPRs) / Certificate of Product Notifications (CPNs)
- Local Good Manufacturing Practice (GMP) Certificate (Local and Foreign)
- Certificate of Compliance (COCs) for X-Ray Facilities under the One-Stop-Shop Licensing System of the Department of Health
- Certificates of Registration for Magnetic Resonance Imaging Facilities
- Special Certification for COVID – 19 Test Kits
Key highlights from the new guidelines
A) Applications for FDA License to Operate (LTO), Certificates of Product Registration (CPR) / Certificates of Product Notification (CPN)
a) Initial LTO / CPR / CPN applications shall be administered online through the FDA e-Portal System or the FDA e-Services System, where appropriate. Priority shall be given to establishments with functions intended for use in the diagnosis, cure, mitigation, treatment, prevention, and for personal preventive equipment (PPE) for COVID-19 and other essential medicines.
b) Inspection of establishments based on FDA Circular No. 2020-027 “Conduct of Risk-Based Local Inspections” shall be subject to priority order and risk assessments.
c) Specific guidelines on initial CPR applications, as applicable to the health product category and/or their center of jurisdiction, shall be issued in the future as separate guidelines.
2. Renewal Applications
a) LTO / CPR / CPN expiring from 01 January 2022 to 30 September 2022 will be automatically extended four (4) months from the original date of expiration provided that a complete renewal application has been filed and acknowledged by the FDA within the extension period.
b) Failure to submit a renewal application within the extension period shall render the authorizations expired and the product shall be subjected to the initial/new product registration which will be subject to the initial filing fees and surcharges
c) For CPRs/CPNs, the automatic validity extension shall not preclude the FDA from revoking the relevant market authorization if evaluation of the application so warrants.
d) Specific guidelines on CPR application renewals, applicable to the health product category and/or their center of jurisdiction, shall be issued in the future as separate guidelines.
e) Extensions provided through Circular no. 2020-024 and this circular are non-cumulative.
f) For transactions with the Bureau of Customs, the following supporting documents shall be provided:
- This FDA Circular
- Acknowledgment receipt
- Official receipt of the renewal application
B) For other certificates/permits
The application is to be carried out electronically, as applicable. Specific guidelines on the filing of applications, where applicable shall be issued in the future as separate guidelines. Existing guidelines in the filing of an application for FDA authorizations remain valid.
C) Payment of Fees and Charges:
- Over-the-counter payments are suspended during the state of public health emergencies
- Payment of fees as indicated in the Order of Payment may be carried out by:
a) Oncoll payment at branches of Land Bank of the Philippines (LBP)
b) Online payment through Bancnet Online Payment Facility (including LBP payment) and LBP Linkbiz Portal.
D) Release of FDA Marketing Authorizations and Certificates:
- Results of applications and scanned copies of the documents shall be sent to the registered e-mail address of the company’s authorized representative.
- For clients within the National Capital Region (NCR), authorizations shall be mailed through courier to the registered mailing address of the company.
- For clients outside of the NCR, authorizations shall be mailed through courier to the respective FDA Regional Field Offices, which have jurisdiction over the concerned company.
This new guideline will come into effect 15 (fifteen) days after its publication and its provisions will remain in effect until the lifting of the Public Health Emergency declaration in The Philippines. Previous guidelines as issued in FDA Circular No. 2020-024 and its amendments that are not in line with the newly implemented FDA Circular are hereby repealed.
Click here for FDA Circular no. 2021-025 from the Philippines FDA.
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