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Market Authorisation of Traditional Medicine in ASEAN Countries
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| Author:
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, MALATHI SESHASAYEE KONDA RAMADOSS, KAILASAM KOUMARAVELOU
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| Abstract:
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Association of Southeast Asian Nations (ASEAN) regions hold a huge market potential for traditional herbal
medicines. To place traditional herbal medicine in the market, it is mandatory to obtain market authorization
of the product. In Malaysia, the Philippines, and Thailand, the registration requirement is satisfied by the
submission of the ASEAN common technical dossier (ACTD). In other member states, they necessitate the
submission based on the requirements particular to their region. This study intends to lay out a systematic
flow in understanding the regulatory approach to address both these requisites and plan document submission.
It provides an insight into planning the product and packaging development process in line with the ASEAN
common technical requirement (ACTR). The labeling regulations across the ASEAN member countries are
also discussed. This information on a common platform will benefit companies to obtain market authorization
without regulatory challenges in ASEAN countries
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| Keyword:
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Traditional Medicine, Market Authorisation, ACTD, ASEAN, Labelling
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.490
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| Download:
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Request For Article
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