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
Hainan Island, popular with Chinese patients for the access it provides to medical devices, global diagnostics and treatments not legally available on the mainland, is now offering an even brighter allure: sharply lower drug prices. A new procurement and bidding system unveiled... Read More
Seeking to stem confusion among drug and medical device manufacturers, China’s regulatory authorities in July released a draft set of rules clarifying how to register products combining both medical devices and pharmaceuticals in the country. The draft Guidelines for the Registration Review... Read More
Signs are emerging that China will tighten its policies governing clinical trials of drugs produced in the country, part of a series of moves to bolster the study of the safety and effectiveness of pharmaceuticals and to bring them fully in line... Read More