Vietnam to ink ASEAN mutual recognition deal on bioequivalence reports
Vietnam will sign the ASEAN Sectoral Mutual Recognition Agreement (MRA) on Bioequivalence (BE) Study Reports on Generic Medicinal Products.
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The Ministry of Health was ordered to comply with Vietnam’s law on international treaties when making amendments and supplements to the MRA’s annex.
The health ministry was also requested to propose a representative to sign the deal.
The MRA will be involve intra-regional acceptance of reports of BE studies conducted by BE centres in ASEAN. It aims to minimise the repetition of BE studies required for marketing authorisation from one ASEAN member state to another.
