Philippines Pharmaceuticals
On September 27, 2022, the Philippine Food and Drug Administration (FDA) published FDA Circular No. 2022-004, the Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Applications. This a welcome development in the bureaucratic registration in the Philippines as the regulatory agency strives to facilitate better drug access through more efficient regulatory mechanisms.
The FDA Circular covers the application of new drugs, including vaccines and biologicals. It will apply to all licensed drug distributors who intend to market or sell products to the Philippine market.
There are two ways for new Drug Products to enter the Philippines: through an Abridged Review or a Verification Review:
1. An Abridged Review refers to a limited independent assessment of specific parts of the dossier or submission for suitability of use under local conditions and regulatory requirements depending on prior assessment from an RDRA. This may be availed when an RDRA has previously approved the drug product, vaccine, or biological and within three (3) years from its approval date.
2. Verification Review refers to the submission of a company evaluated and approved by at least two (2) RDRAs. The local FDA validates the submission and ensures its conformance with the registration conditions, standards, and requirements as approved by the RDRAs.
Documentary requirements for new drugs, vaccines, and biologicals include:
1. A formal, written request from the applicant drug distributor
2. Assessment report from the RDRA/s
3. A valid certificate of Pharmaceutical Product (CPP) following the WHO Certification Scheme
4. Complete International Council for Harmonization of Technical Requirements for Pharmaceutical for Human Use (ICH) Common Technical Document (CTD) or ASEAN Common Technical Dossier (ACTD) data.
5. Stability studies under climatic Zone IVB (hot and very humid)
6. Proposed Package insert / Patient Information leaflet identical to that approved by the RDRA and country-specific requirements specified by the Philippine FDA.
A list of eligible products, a complete list of documentary requirements, and applications for RDRA’s post-approval changes can also be found in the FDA circular.
The Abridged Review and Verification Review will have an approval time of not more than 45 working days and not more than 30 working days, respectively. Turnaround time will start after the receipt of the proof of payment with the completion of the dossier application.
There are fourteen (14) Reference Drug Regulatory Agencies (RDRAs), including the U.S. Food and Drug Administration, the European Medicines Agency (EMA) of the European Union, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, and Health Canada, among others.
You may view this link to read about FDA Circular 2022-004 or Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications.
The U.S. Commercial Service can assist you in understanding local regulatory requirements. Please contact Commercial Specialist Katrina Domingo at katrina.domingo@trade.gov to learn more.