China

Regulatory

The Chinese agencies for regulating drugs and medical devices are The National Medical Products Administration (NMPA) and the Ministry of Science and Technology (MOST). Clinical trial applications can be submitted to NMPA for Phase I through Phase IV clinical trials, including bioequivalence trials, that are conducted in China. Clinical trial application will be considered approved after 60 working days if the applicant does not receive a rejection or an inquiry for clarification from the NMPA.

An ethics committee (EC) must approve a clinical trial application prior to a sponsor initiating a clinical trial. The EC review may be submitted in parallel to the NMPA’s review, but the study cannot be initiated until after review and approval by the EC. The EC must give written notice of its decision to the applicant within 10 working days after the review.

Official links

Link: https://clinregs.niaid.nih.gov/country/china#safety_reporting

Pharmaceutical Industry & Clinical Trials Market

China is the second biggest pharmaceutical market in the world, with a large middle-class population and increasing levels of disposable income.

The number of new clinical trial starts in China has almost tripled since 2016 and is continuing to rise. China has 29,140 hospitals and over 1 million independent outpatient clinics. There is a large and growing network of qualified hospitals to conduct trials and skilled clinical trial project leaders. There is also government support for international partnerships and an improved regulatory environment for trials and new drug approvals.

Medical System in China

China does have free public healthcare which is under the country’s social insurance plan. The healthcare system provides basic coverage for the majority of the native population. As of 2020, about 95% of the population has at least basic health insurance coverage. Basic medical insurance includes two systems: employee medical insurance and resident medical insurance. The former covers the urban employed population, and the latter covers the urban non-employed population and the rural population.

The country maintains two parallel medical systems, one for modern or Western medicine, and one for Traditional Chinese medicine (TCM).

China has made significant progress in improving public health and in recent years has become a growing hub for healthcare research and development.