Page 49 - 2023 Taiwan Food and Drug Administration Annual Report

3Advancement of Drug
Management

manufacturers (including those dedicated was completed in 2022, and a total of 29
for export) and pharmaceutical companies API manufacturers and 155 pharmaceutical
engaged in wholesaling, importing and companies engaged in wholesaling, importing,
exporting APIs should comply with GDP and exporting APIs have obtained the western
before December 31, 2022. TFDA assists pharmaceutical distribution license (GDP
the industry in familiarizing with and licenses). By the end of 2022, a total of 940
implementing GDP through holding training pharmaceutical dealers have obtained GDP
courses and on-site visits to implement authorization.
the distribution management of medicinal
products gradually. Section 4

▍ Achievements and Benefits Actively Participate
in Events of
I. Ensured fulfillment of the International
GMP in the manufacturing of Organizations for
medicinal products Medicinal Products

As of the end of 2022, a total of 149 ▍ Introduction of the Policy
domestic pharmaceutical manufacturers and
958 overseas pharmaceutical manufacturers In order to deepen and promote
have been approved through the GMP international exchange and collaboration,
inspections performed by TFDA; it ensures TFDA has been proactively taking part in
the medication quality for the public. TFDA APEC (Asia-Pacific Economic Cooperation),
announced the addition of “Annex 2A: ICH, and PIC/S events, maximizing the
Manufacture of Advanced Therapy Medicinal engagement and influence of our country
Products for Human Use” and the revision in international drug administration and
of “Annex 2B: Manufacture of Biological strengthening bilateral and multi-lateral
Medicinal Substances and Products for Human cooperation by exchanging with and sharing
Use” on July 27, 2022; the GMP regulations experience with international regulatory
keep pace with the times and international. authorities.

II. Ensured fulfillment of the ▍ Implementation Strategy
GDP in the distribution of
medicinal products 47

The implementation of GDP on APIs