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ASEAN develops mutual recognition arrangement for bioequivalence
Representatives of the ASEAN Pharmaceutical Product Working Group (PPWG), which comprises national drug regulatory authorities in ASEAN member countries, are discussing the harmonization of and recognized arrangements for the acceptance of bioequivalence (BE) study reports produced by bioequivalence centers in ASEAN in a two-day workshop in Jakarta, which will end on Thursday
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epresentatives of the ASEAN Pharmaceutical Product Working Group (PPWG), which comprises national drug regulatory authorities in ASEAN member countries, are discussing the harmonization of and recognized arrangements for the acceptance of bioequivalence (BE) study reports produced by bioequivalence centers in ASEAN in a two-day workshop in Jakarta, which will end on Thursday.
'The workshop is expected to come up with recommendations on the content of the mutual recognition arrangement (MRA) for further consideration by the PPWG,' ASEAN Secretariat said in a press statement in Jakarta on Wednesday, as quoted by Antara news agency.
It said the MRA formulation was expected to be completed in 2015.
'Harmonization and providing recognition to the bioequivalence study reports in ASEAN member countries will benefit the pharmaceutical industry,' said ASEAN Secretariat.
'It will prevent the need for multiple study reports for new generic drugs, facilitating intra-ASEAN trade and development of the drug industry.'
The ASEAN Consultative Committee on Standards and Quality of the PPWG has been working to develop coordinated technical requirements for the pharmaceutical sector since the establishment of the group, in accordance with its objectives to eliminate technical barriers to trade in the sector.
The PPWG has developed and implemented similar technical requirements, including the ASEAN Common Technical Dossier and the ASEAN Common Technical Requirements.
The PPWG began the implementation of an MRA for good manufacturing practice inspections of medicinal product manufacturers in 2009. (ebf)(++++)
