This Administrative Order is issued to establish an accelerated review process for prequalified pharmaceutical products and vaccines, through the adoption of the WHO CRP into the national registration procedures and requirements.
This Administrative Order shall apply to all FDA-licensed drug distributors, traders, and manufacturers with WHO Prequalified vaccines or drug products for registration in the country.
The FDA hereby adopts the current version of the Annex 8 of WHO TRSNo. 996, “Collaborative procedure between the World Health Organization Prequalification Team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines’’, including all further supplements and revisions related thereto, as an alternative registration
pathway for drug products, including vaccines.
Only FDA-licensed drug distributors, traders, and manufacturers with WHO Prequalified vaccines or drug products may apply for a Certificate of Product Registration through the Collaborative Procedure pathway.
Procedural guidelines, including the application process, documentary requirements, forms, and evaluation processes shall be issued via separate FDA Circular, for effective and efficient implementation of this Order.
For more information, please refer to https://www.fda.gov.ph/wp-content/uploads/2020/09/Administrative-Order-2020-0044.pdf?fbclid=IwAR0gKt9R6L2RX7_quyC2y92DAtgJDnV4hqMuFcTHkFub2eZlNbA5w2lROto