Taiwan Implements GMP/GDP for API Manufacturers

Taiwan FDA has announced that API manufacturers must 1) from 27 July 2020, API manufacturers (including those only for export) who are new, relocated, or resuming, shall apply for and meet the requirements of the Good Manufacturing Practice (GMP) for Medicinal Products; 2) apart from those mentioned in (1), other API manufacturers (including those only for export) shall comply to the GMP before 31 December 2021.

Companies that distribute, import, or export AP must 1) apply for the evaluation of GDP from 1 January 2021 and 2) meet the standards of the Good Distribution Practice for Western Medicines before 31 December 2021.


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