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TAIWAN: MOHW announces the revision of GMP Guidelines on Medicinal Products with immediate effect

2022/08/05  MOHW

The Minister of Health and Welfare announced on July 27 issued an official letter to announce the revision of the GMP Guidelines on Medicinal Products.

This revision is based on Article 3 of the GMP Guidelines and aims to reflect the update of the PIC/S:Guide to Good Manufacturing Practice for Medicinal Products announced last year.

The revision includes the addition of Annex 2A (MANUFACTURE OF ADVANCED THERAPY MEDICINAL PRODUCTS FOR HUMAN USE) and the amendments to Annex 2B (MANUFACTURE OF BIOLOGICAL MEDICINAL SUBSTANCES AND PRODUCTS FOR HUMAN USE). The revision takes effect from the date of the announcement.

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