Geneva, Switzerland hosted the 52nd Pharmaceutical Inspection Cooperation Scheme (PIC/S) Committee Meeting on May 11 and 12, 2023. Director General Samuel A. Zacate led the delegation for the Philippine Food and Drug Administration to the meeting.
The meeting’s agenda includes discussion on issues related to capacity building, drafting of upgraded versions of GMP standards including Good Distribution Practices, Good Storage Practices, Good Clinical Trial Practices, as well as processing of PIC/S membership applications including Philippine FDA’s application which was filed on 04 May 2023. It may be recalled that in 2019, the Philippine FDA has successfully qualified as the fifth ASEAN Listed Inspection Service which significantly improved the likelihood to be accepted for PIC/S Membership.
The accession to PIC/S is a solid foundation that supports regulatory recognition and reliance, especially for GMP clearance and product market authorization. Philippine FDA’s accession to PIC/S shall support the acceptance and authorization of locally manufactured products in the global market through the WHO Pre-qualification Scheme or through product licensing by a Stringent Regulatory Authority.
In order to emphasize the importance of PIC/S Accession, Director General Samuel A. Zacate spoke on behalf of the FDA Philippines, the country’s national drug regulatory agency. The Philippine delegation also engaged with counterparts from other countries, seeking their support for the Philippine FDA’s membership application.