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The ASEAN harmonization of technical standards on health supplements – an industry perspective

Jul 06, 2021

Many countries in the Association of Southeast Asian Nations (ASEAN) require registration of health supplements, which generally takes a few months to years. There have been many different interpretations of the principle-based standards or regulations among the ASEAN member nations, making right-first-time regulatory submissions for the region hard to achieve and, absent defined review limits (such as rounds of questions/letters of deficiencies), lead times for approvals can be long and variable. Although it is recognized there is much to be done, harmonization of the proposed 10 sets of technical standards is expected to be a major first step forward in enabling regulatory submissions and reviews of health supplements in the ASEAN region.

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