ASEAN Mutual Recognition Arrangement for Bioequivalence Study Reports of Generic Medicinal Products: Study on Readiness, Impacts, Policy Recommendation and Action Plan to Reduce Negative Impacts
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Abstract
In November 2017, ASEAN Member States signed ASEAN Mutual Recognition Arrangement for Bioequivalence Study Reports of Generic Medicinal Products (ASEAN BE MRA) resulting in both positive and negative impacts on Thailand. It can help reduce cost from unnecessary repetition of BE studies across ASEAN. It can also have repercussion on potential of pharmaceutical industry competitiveness. The objectives of this study were to study on operational procedurestowards MRA signing and implementation for ASEAN and Thailand,to analyze and anticipate the impacts of ASEAN BE MRA and readiness of stakeholdersinvolved in order to propose policy recommendation and action plan to alleviate the negative impact. Documentary research and qualitative research were conducted. Qualitative data were collected through public hearing, focus group and questionnaires from all stakeholders.The results showed that private sectors directly affected by the impacts such as Bioequivalence Centres and local pharmaceutical Industry have serious concerns on impacts toward pharmaceutical business, less competitiveness due to high cost of bioequivalence study, non-tariff barriers from some Member Countries including the issue on readinessof government sector in terms of increasing efficiency and reducing approval timelines.All relevant pharmaceutical private sectors needed government supports from various relevant public sectors and requested for measures of remedy to lessen the impact of ASEAN BE MRA. Policy recommendation and action plan were developed. Proposed recommendations were (1) to set subcommittee responsible for considering the strategic plan and measure to alleviate the impact resulting from ASEAN BE MRA (2) to implement work and response according to the stakeholder requests on review and approval (3) to prepare qualified reviewers and inspectors for bioequivalence study (4) to propose strategic plan in order to alleviate the existing impacts
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