Quick Asian Drug Regulatory Updates

On July 31, 2024, the Taiwan Food and Drug Administration (TFDA) officially launched digital GMP certificates. These certificates comply with international PIC/S GMP standards and feature advanced encryption via a digital signature recognized by Taiwan’s Electronic Signatures Act and the global Adobe Approved Trust List. These certificates can be quickly verified via QR code scanning or a PDF verification platform, which has already verified over a thousand certificates. This program is in line with Taiwan’s commitment to improve the oversight of pharmaceutical manufacturers to ensure the safety and efficacy of drug products in their market.

In early January, China’s NMPA announced 2 new appendices related to GMP for drug excipients and drug packaging companies. The Appendices will become law on January 1, 2026. For manufacturers of excipients and drug packaging materials, upgrading their facilities will be mandatory. They will need to strengthen their QMS systems, implement better change management systems, and better support MAHs during audits. For MAH holders in China, they will now need to increase their supervision of excipient and drug packaging manufacturers, do more thorough quality audits of their suppliers, further evaluate the quality control of their suppliers, and more closely track changes that may affect the quality of their drugs.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)

Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.