Association of Southeast Asian Nations Pharmaceutical Product Working Group (ASEAN PPWG)

History

The ASEAN PPWG was established in 1999 by the ACCSQ (ASEAN Consultative Committee for Standards and Quality).

Current Members

Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Phillipines, Singapore, Thailand, and Vietman.

Mission

The mission of the PPWG is to develop harmonisation schemes of pharmaceutical regulations of the ASEAN Member countries to complement and facilitate the objective of AFTA (ASEAN Free Trade Area), particularly, the elimination of technical barriers to trade posed by regulations, without compromising on drug quality, efficacy, and safety.

Scope of PPWG's Activities

The PPWG's scope of harmonisation/cooperative activities includes:

  • the discussion of existing technical guidelines and regulatory requirements;
  • the study of harmonised procedures and regulatory systems currently implemented in other regions relating to technical guidelines and regulatory requirements;
  • the harmonisation of technical guidelines and regulatory requirements applicable to the ASEAN pharmaceutical industry;
  • the development of Common Technical Documents with a view to arriving at Mutual Recognition Arrangement (MRAs).

The scope of pharmaceutical products covered by the PPWG includes New Chemical Entities (NCEs), biotechnological products, major and minor variation products, and generics.