Alignment with International Pharmaceutical GMP Standards: Synchronizing the Regulation of Domestic GMP with Global Practices
【Update Date：2025-09-02】unit：品質監督管理組
The Taiwan Food and Drug Administration (TFDA) serves as an independent and professional authority overseeing GMP inspection of medicinal products. Through rigorous training programs, TFDA has professional GMP inspectors and instituted a dedicated inspection framework. In 2013, Taiwan became a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), thereby introducing an internationally recognized inspection framework. This alignment has gradually harmonized the GMP standards and regulatory oversight of Taiwan’s pharmaceutical manufacturers with global practices. Consequently, the public now has access to medicines that meet international quality standards, while the competitiveness of domestically manufactured pharmaceuticals has been significantly enhanced. As of now, 144 pharmaceutical manufacturers and 28 active pharmaceutical ingredients manufacturers in Taiwan have been certified as compliant with PIC/S GMP requirements.
To safeguard drug quality and patient safety, TFDA conducts routine inspections of pharmaceutical manufacturers every two to four years, and may also initiate unannounced inspections when necessary. These measures ensure that domestic manufacturers consistently comply with GMP standards. In response to evolving international trends and regulatory challenges, TFDA remains committed to strengthening pharmaceutical GMP management, upholding manufacturing quality, and ensuring the patient safety of medicines.