The latest round of negotiations between the Chinese government and pharmaceutical firms has yielded massive price cuts for consumers in the country on more than 65 new brand-name drugs in return for access to the second-largest pharmaceutical market in the world. The... Read More
More and more device purchasing in China is done via government tenders and procurement. China is now signaling it may ease rules that prohibit foreign companies from obtaining lucrative government procurement deals. That could be good news for foreign medical device manufacturers... Read More
China’s National Medical Products Administration (NMPA) in November announced the creation of a platform to collect information related to all active pharmaceutical ingredients (APIs) in circulation in the country. The new platform will allow NMPA, which drafts laws and regulations for drugs,... Read More
Moving with increasing urgency to encourage the development of drugs to treat rare diseases, Chinese regulators are planning for the first time to authorize real-world studies of orphan drugs. Technical guidelines released in October by the National Medical Products Administration’s Center for... Read More
Recently, China came out with Order 739 which has a number of new device regulations. Some of the new regulations include – 1. the use and acceptance of different types of evidence for clinical evaluation, 2. a waiver of country-of-origin approval for... Read More
This article was originally published on MedTech Intelligence. China’s medical device market has grown tremendously over the last five years. While estimates vary on the total size (somewhere around $50 billion), many foreign companies have grown their business there. Accounting for about... Read More
Moving to modernize and standardize regulatory review of documentation from pharmaceutical manufacturers, Chinese regulators are launching a pathway to submit pharmaceutical applications, supplements, and reports to authorities using the electronic Common Technical Document (eCTD). The Center for Drug Evaluation of the National... Read More
Local type testing is a requirement for doing clinical trials and registering devices in China. In a bid to foster innovation in the development of medical devices without sacrificing safety, China’s medical device regulatory agency announced in October it will permit foreign... Read More
Racing to keep up with the challenges of a fast-expanding biotech sector, China’s regulators are beginning to erect guardrails on how startups can develop, test, and register new drugs. Since September, the National Medical Products Administration (NMPA) has issued more than 15... Read More
Harnessing new technologies to better evaluate the efficacy of new drugs, regulators in China are beginning to incorporate data, videos, and photos drawn from monitors worn by patients who agree to the use of the information. The country’s Center for Drug Evaluation... Read More