China’s law (Implementing Regulations of the Drug Administrative Law) is currently being updated and out for public comments until June 9. The draft regulation includes over 181 articles or over 100 more articles than the current law. Some possible changes among other... Read More
Opportunities in China for novel drugs will continue to grow despite recent NRDL price cuts. For example, Novartis sales in China are close to $3.1 billion a year, and last year sales grew by double digits. 2025 sales are expected to top $4.2 billion... Read More
On April 22, the NMPA’s Center for Medical Device Evaluation (CMDE) and the Hainan Medical Product Administration (MPA) announced the Hainan Communication Standard Operating Procedure (SOP) for Medical Device Clinical Real-World Data Applications. This announcement details the regulatory process to register non-approved... Read More
Digital healthcare trends are flourishing in Asia due to its aging population, shortage of healthcare personnel, increasing consumer demand, and technological innovation. According to statistics from Graphical Research, the digital health market in Asia Pacific is expected to grow by 33% from 2020... Read More
Starting May 1, the China National Supervision Administration updated the 2014 Measures on the Supervision and Administration of Medical Devices Manufacturing. These measures put in effect more rigorous regulatory manufacturing requirements and increased the responsibilities of medical device manufacturers and third-party OEMs. While... Read More
This article was first published on MedTech Intelligence. Everyone knows China has a large medical device market. Over the last 30 years and up until a few years ago, opportunities for device sales in China were good for many Western device companies.... Read More
In the past, hospitals made money in China by marketing up drugs, devices, procedures, and doing many diagnostic tests. Those days are over. As mentioned in our previous newsletters, China’s Volume Based Procurement (VBP) has cut the reimbursements for many high priced... Read More
On March 21, 2022, China’s Ministry of Science and Technology (MOST) released the draft version of the Implementing Rules for Human Genetic Resources Management to seek public opinion by late April. The release of this document signals the Chinese authorities’ intention to help facilitate clinical... Read More
The China NMPA recently announced that the updated China Good Clinical Practice (GCP) for Medical Devices will come into effect on May 1, 2022. The GCP was promulgated in 2016 in order to ensure the quality of medical device clinical trial management,... Read More
Global regulators are increasing their watch on antitrust issues, pricing issues, IP, patent laws, etc. China’s regulators are doing the same and earlier this year issued 2 policy reports – The Fourteenth Five Year Modernization of Market Regulation Plan and the Fourteenth... Read More