Many foreign device and drug companies now doing clinical trials, R&D, data collection and other related medical activities in China need to follow China’s HGR regulations. HGR regulations outline what foreign companies need to do when applying for, filing and reporting relevant... Read More
While robotic surgical devices have penetrated much of the US and Europe, future growth is expected to be strongest in Asia. It is estimated that Asian surgical robotic sales will hit $10 billion in 5 years. Asia’s quickly aging population and the... Read More
On August 8, the 9th round of Volume Based Procurement (VBP) was released, and the gathering of volume usage was closed on September 11. The 9th round of VBP included 44 drugs, according to the Chinese health authorities. The 44 drugs include... Read More
On May 20, known as International Clinical Trials Day in China, a number of Chinese hospitals and related groups provided an in-depth educational session to help enlighten Chinese patients about participating in local clinical trials. Over 30,000 Chinese attended these informational sessions,... Read More
On August 17, the NMPA announced that its classification catalog would be adjusted given the influx of new innovative devices. Fifty-eight product categories have been updated. However, only 4 product categories have been changed from Class 1 to Class 2 or from... Read More
China’s Center for Drug Evaluation (CDE) issued new guidelines in late July supporting the use of DCT via telemedicine to allow clinical trials to be done remotely. The DCT guidelines may be implemented as long as investigators and sponsors agree and the... Read More
While bribery has been significantly reduced in China’s medical market over the last five years, it still exists. For example, there have been significant reductions of payments to NMPA officials for drug approvals. However, in other areas of the Chinese medical system,... Read More
Advanced healthcare is limited in China due to restrictive pricing schemes that reduce payments. Programs like the drug reimbursement list, diagnosis-related groups (DRGs), and Diagnostic Intervention Packets (DIPs) limit reimbursements and thus make expensive new therapies unaffordable in China. To counter these... Read More
According to a recent market research report by Triton Market Research, Asia’s CDX market was valued at $1.4 billion in 2022 and is likely to grow to $3.85 billion by 2030 with a CAGR of 13%. While CDX growth has already accelerated... Read More
China is the second-largest drug market in the world. Registering drugs in China is more accessible today than ever. That does not mean it is easy or straightforward. Before attempting to do so, international drug companies should research the prevalence of the... Read More