Thursday, November 10, 2016

Vietnam to sign ASEAN mutual recognition deal on bioequivalence study reports

Vietnam will sign the ASEAN Sectorial Mutual Recognition Agreement (MRA) on Bioequivalence (BE) Study Reports on Generic Medicinal Products.
Photo for illustration (Source: Biospectrum)
Under a recently issued resolution on the deal, the Vietnamese Government agreed on the draft MRA and allowed an official of the Ministry of Industry and Trade to sign the document.
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 involved intra-regional acceptance of reports of BE studies conducted by BE centers in ASEAN. It aims to minimize the repetition of BE studies required for marketing authorization from one ASEAN member state to another.
Source: VNA


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