Dear Sir / Madam,

With the reference to the subject matter above, kindly be informed that 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 (FDA) under the ASEAN Mutual Recognition Arrangement (MRA) on Good Manufacturing Practices (GMP) effective 7th January 2020.

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

The ASEAN MRA on GMP sets out arrangements under which each signatory of the MRA, shall accept:

1. The GMP certificate for manufacturer of medicinal products, where the GMP certificates are issued by a listed inspection services; and
2. 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.

NPRA, Malaysia will accept and recognize the GMP certificate for manufacturer of medicinal products as well as GMP inspection reports issued by Phillipines FDA. Therefore, GMP evidence based on inspection conducted within 6 months prior to the endorsement and confirmation of Philippines FDA as ASEAN Listed Inspection Services shall be acceptable.

For additional information regarding Foreign GMP Inspection, kindly refer to the links below:

• FAQs Foreign Inspection January 2020
• Guidance Document Foreign GMP Inspection

Your attention regarding this matter is highly appreciated.