China Directs New Regulatory Focus towards Burgeoning Biotech Market

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 new requirements and guidance on the development of drug therapies. The flurry of regulatory activity comes in response to the acceleration of the biopharma sector, fueled by the development of cell, mRNA technologies, etc. Since 2016, the number of clinical trials of biopharmaceuticals in China has grown in double digits each year.

New regulations imposed by NMPA involve CAR-T risk assessments, requirements for filing orphan drug trial study designs, and a mandate to list reference drugs for generic bioequivalence testing.