Representatives of the ASEAN Pharmaceutical Product Working Group (PPWG) discussed bioequivalence study reports on the bloc’s pharmaceutical products in a workshop on October 21-22.
The event was jointly organised by the ASEAN Consultative Committee on Standards and Quality (ACCSQ) and the bloc’s Secretariat as part of the ASEAN Regional Integration Support from the EU programme (ARISE) which aims to enhance economic integration by eliminating technical barriers to trade in the pharmaceutical sector.
Representatives discussed key pharmaceutical issues and the international requirements for registering drugs of the same type as bioequivalent.
The PPWG has been studying the mutual recognition arrangement (MRA) since 2009 with a view to establishing an MRA for pharmaceuticals by 2015. The working group promotes the harmonisation of production and the recognition of bioequivalence study reports put forward by ASEAN bioequivalence centres.
The MRA will benefit the region’s pharmaceutical industry and create favourable conditions for trade.
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