ASEAN Develops Mutual Recognition Arrangement for Bioequivalence Study Reports

JAKARTA, 22 October 2014 - A two-day workshop for representatives of Pharmaceutical Product Working Group (PPWG) or the National Drug Regulatory Authorities from ASEAN Member States was held on 20-21 October in Jakarta, Indonesia. An expert from EU presented background issues and international requirements for registration of generic drugs and for bioequivalence studies.

The ASEAN Consultative Committee on Standards and Quality (ACCSQ) PPWG, in accordance with its objectives in eliminating technical barrier to trade in the pharmaceutical sector, has been undertaking work on developing harmonised technical requirements for this sector since its establishment. The PPWG had developed and implemented several harmonised technical requirements including the ASEAN Common Technical Dossier (ACTD) and ASEAN Common Technical Requirements (ACTR).  In 2009, PPWG started the implementation of a mutual recognition arrangement (MRA) for Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products.