27 DECEMBER 2019
ASEAN Member States officially listed the Philippine Food and Drug Administration (FDA) under the ASEAN Mutual Recognition Arrangement (MRA) on Good Manufacturing Practices (GMP) for Medicinal Products during the 28th ASEAN Consultative Committee on Standards and Quality Pharmaceutical Product Working Group (ACCSQ-PPWG) Meeting held on 19-20 December 2019 in Indonesia. The endorsement was agreed upon after the ASEAN Panel of Experts’ assessment of the FDA and successful establishment of the agency’s technical competency for inclusion in the register of accepted ASEAN Inspection Services.
As listed Inspection Service of the ASEAN MRA, the (1) FDA issued GMP Certificate for manufacturers of medicinal products, and (2) FDA GMP inspection reports shall be accepted by other listed National Regulatory Agencies under the ASEAN MRA on GMP.
Undersecretary of Health and FDA’s Officer-In-Charge (OIC) Director General, Rolando Enrique D. Domingo underscored the importance of the inclusion of the FDA in the ASEAN registry for both the industry and consumers. For the industry, the inclusion will result in reduced duplication of inspections, cost reduction, facilitation of exports, enhanced market access, enhanced industry reputation, transparency in inspection standards and consistency of inspection. The inclusion will also increase confidence in the quality of medicines for consumers, increase in reliability and quality of medicines, improved consumer safety and protection, better control of counterfeit medicines, and improved access to affordable quality medicines.
USec Domingo also emphasized that the successful inclusion “is a major step and contribution of the FDA to the government’s strategy to expand economic opportunities in industry and services through Trabaho at Negosyo as mandated by Philippine Development Plan (PDP) 2017-2022 anchored on a long-term vision or AmBisyon Natin 2040.”
The Philippines is the fifth country to be listed under the ASEAN MRA on GMP for Medicinal
Products after Singapore Health Sciences Authority, Malaysia National Pharmaceutical Regulatory Authority, Indonesia National Agency of Drug and Food Control and Thailand Food and Drug Administration.