FDA Circular No. 2021-025 was issued last year and has been the guidance for regulatory flexibilities on FDA-issued marketing authorizations considering the pandemic and economic challenges brought by COVID-19.
In the light of the service, the FDA released an amendment of the circular stating that the effectivity is extended from October 01, 2022 until December 31, 2022. Moreover FDA-issued authorization covered by the circular are automatically extended
The following are the FDA-issued authorizations covered by the circular and its amendment.
- • Licenses to Operate (LTOs)
- • Certificate of Product Registration / Certificate of Product Notification (CRPs/CPNs)
- • Local Good Manufacturing Practice (GMP) Certificates
- • Certificate of GMP Compliance (COCs) for x-ray facilities under the One-Stop Shop Licensing
- • System of the Department of Health (DOH)
- • Certificates of Registration (CORs) for Magnetic Resonance Imaging (MRI) facilities
- • Special Certification for COVID-19 Test Kits
Guidelines for application of authorization at FDA during pandemic
Effectivity Extension of FDA Regulatory Flexibilities on Pandemic