China Drafts Major New Rules for Registering Pharmaceutical-Device Combination Products

For the first time in twelve years, Chinese regulators are drafting updates to government regulations on therapeutic and diagnostic products that combine drugs and medical devices.

The draft updates released by the National Medical Products Administration (NMPA) include eight major changes designed to address the growing sophistication and integration of drug-device combination products being brought to market. The products are gaining in importance for patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis, and diabetes.

Among the changes being drafted is the language that puts the burden on manufacturers to meet registration requirements in China, rather than in a products’ country of origin. The draft updates also include a new set of technical review mark posts for future applicants seeking to register their products in China.