ASEAN Regional Integration Support from the EU

ASEAN Member States Sign Mutual Recognition Agreement (MRA) of Bioequivalence Study Reports of Generic Medicinal Products

The ACCSQ Pharmaceutical Product Working Group (PPWG) in furtherance of 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 2004. PPWG successfully established a mutual recognition arrangement for Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products in 2009. Since then, the group has been actively working to further advance harmonisation of regulatory requirements for pharmaceuticals. One of its initiatives which has now developed to an advanced stage of implementation is the acceptance of Bioequivalence Study Reports.

The PPWG has finalised a recognition arrangement that will lead to the mutual acceptance of Bioequivalence Study Reports produced by Bioequivalence Centres in ASEAN that are listed in accordance with the MRA. The recognition arrangement will benefit the pharmaceutical industry in avoiding the need for multiple study reports for obtaining the marketing authorisation for new generic drugs in the ASEAN Member States (AMS). With this MRA becoming operational, a study report by a listed ASEAN Bioequivalence (BE) Centre will be recognised across all 10 AMS eliminating the need for duplicate processes.

As a result of this initiative trade and development of the pharmaceutical industry across ASEAN will be facilitated. This will benefit various different stake holders across AMS including the pharmaceutical industry, medical practitioners, the pharmaceutical businesses and most importantly the wider ASEAN community when more generic drugs with assured quality are available across the region at affordable prices.

ARISE has extended support to enable progress in the intended direction by supporting several workshops throughout the years. These concerted efforts over several years has let to all AMS signing the MRA of Bioequivalence (BE) Study Reports of Generic Medicinal Products and it has come into force since the signing of the MRA on 2 November 2017.

The PPWG is now finalising the technical documentation and implementation schedule to commence the implementation of the MRA. ARISE Plus has continued to provide technical and logistics support to the PPWG. A workshop on Implementation of Mutual Recognition Arrangement of Bioequivalence Study Reports of Generic Medicinal Products, was organised in Kuala Lumpur, Malaysia from the 27-28 March 2018. This workshop has resulted in the development of the final draft on the Procedures for the Assessment of BE Centres in ASEAN that will be listed in accordance with the MRA. The listed BE Centres would be enabled to serve all of AMS in producing BE study reports that will be recognised throughout the AMS. The PPWG is aiming to finalise the operating procedures by the end of 2018 and to commence implementation thereafter.

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