Archives

img-01

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... Read More

img-01

China Implements New IVD Classification Codes

Within the China NMPA is the medical device regulatory division called the Center for Medical Device Evaluation (CMDE). The CMDE covers both medical devices and IVDs. On May 10, 2024, the CMDE issued the Announcement of the IVD Classification Catalog. This new... Read More

img-01

China Further Expedites Innovative Drug Approvals in Greater Bay Area and Yangtze River Delta

In late October, China’s NMPA announced that they had started a new program in 2 locations to simplify the process for the approval of innovative drugs. “Advanced Acceptance Services” will become available for applications qualified for priority review or conditional approval as early as November 1, 2024 – following appropriate pre-application consultations.... Read More