The FDA Philippines (FDAP) has been approved to join the regulatory agencies of Singapore, Malaysia, Indonesia, and Thailand on the Association of Southeast Asian Nations (ASEAN) Listed Inspection Services (LIS), after an extended review process that included documentary, on-site, and in-process inspection assessment.
The ASEAN member states approved the Philippines agency for inclusion at the December 16-20 meeting of its Consultative Committee for Standards and Quality (ACCSQ) Pharmaceutical Product Working Group (PPWG), held at the ASEAN Secretariat headquarters in Jakarta, Indonesia.
The ASEAN member states signed a Mutual Recognition Agreement (MRA) on GMPs in 2009. Three years later, in 2012, a Joint Sectoral Committee (JSC) was formed to implement the MRA and establish the LIS register.
ASEAN is using the standards and framework of the international Pharmaceutical Inspection Cooperation Scheme (PIC/S) in assessing eligibility for LIS inclusion.
The ASEAN MRA currently encompasses the PIC/S inspection standard Part I on GMPs for medicinal products, but not yet Part II on API GMPs. Duplicating the EU GMPs, Part I covers: ● the pharmaceutical quality system ● personnel ● premises and equipment ● documentation ● production ● quality control ● outsourced activities ● complaints and product recall, and ● self-inspection.
All the PIC/S annexes are included, with the exception of Annex 2 on biologics, Annex 7 on herbal medicines, and Annex 13 on investigational medicinal products.