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Asia: Philippines FDA included in list of ASEAN inspection services

2020/01/09

At the 28th ACCSQ Pharmaceutical Product Working Group (PPWG) Meeting and its related meetings, ASEAN Member States agreed to endorse the listing of the Philippines Food and Drug Administration under the ASEAN Mutual Recognition Arrangement (MRA) on Good Manufacturing Practices (GMP). The five-day event was held from December 16 at the ASEAN Secretariat.

The listing of Philippines FDA will be an addition to the current listed inspection services under the ASEAN MRA on GMP, which includes the Singapore Health and Sciences Authority, Malaysia National Pharmaceutical Regulatory Authority, Indonesia National Agency of Drug and Food Control and Thailand Food and Drug Administration.

The ASEAN MRA on GMP sets out arrangements under which each signatory of the MRA, shall accept (i) the GMP certificate for manufacturers of medicinal products, where the GMP certificates are issued by a listed inspection service; and (ii) the GMP inspection reports which verify conformity of a manufacturer of medicinal products with the mandatory requirements, where such inspection reports are issued by the Listed Inspection Service. Currently, the coverage of the MRA includes conventional pharmaceutical products in finished dosage forms.

The GMP certificate is a mandatory requirement for registration of medicinal product in each ASEAN Member States.

To continue reading this article please go to ASEAN .