In mid-February, China’s Center of Drug Evaluation (CDE) under the NMPA promulgated two new guidelines. The first guideline was titled – The Guideline for Acceptance and Review of Chemical Drug Registration (trial) – which will begin on March 10 of this year. This... Read More
China’s skyrocketing development of artificial intelligence (AI) will further enhance the country’s digital health industry, GlobalData announced. The new releases of recent AI models Qwen2.5-Max, Kimi k1.5, and DeepSeek v3 demonstrate China’s rising stakes in the arena of AI and its influence... Read More
About 7 years ago, China initiated a volume-based procurement (VBP) policy to award drug companies with large sales opportunities but at significantly lower prices – oftentimes, VBP winners have drug price discounts of 50% to 90%. There have been 10 rounds of VBP... Read More
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
In late 2024, the National Medical Products Administration of China (NMPA) and six other government agencies published the Draft Administrative Measures for Management of Medical Representatives (Draft Management Measures) to update the 2020 Record-Filing Measures. The goal of this publication is to further... Read More
Over the last 15 years, China has been good at replicating and making good generic drugs and more sophisticated devices. Over the last few years, with the help of massive investment from the Chinese government and gobs of new local and foreign... Read More
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
In late November, China’s National Health Care Security Administration added 90 new drugs to the NRDL. At the same time, 44 drugs were deleted. Now the NRDL has over 3,160 drugs, about 1,770 of which are chemical and biological drugs, with the... Read More
In late November, China’s Joint Drug Procurement Office promulgated the 10th round of Volume Based Procurement (VBP). To be eligible for this bid of 60 drugs, applicants needed to submit their price proposals by mid-December. Of these 60 drugs, there were eight... Read More
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