The National Medical Products Administration (NMPA) of China has issued a new set of regulations concerning the administration and management of export drug manufacturing, with a public consultation period open until September 10, 2024. The regulations define export drugs as those manufactured by Chinese companies and intended for export to other countries or regions, including both drug preparations and active pharmaceutical ingredients (APIs).
Under these regulations, pharmaceutical production enterprises that manufacture and export drugs are held primarily responsible for the quality and safety of their exported products. They must ensure that the entire drug production process adheres to the relevant laws and regulations of both China and the importing countries or regions.
For drug production enterprises that use their production scope or lines for the manufacture of export drugs, they are required to apply to the provincial medical products administrations for a drug Good Manufacturing Practice (GMP) compliance inspection. Upon successful inspection, the medical products administration will issue a “Notice of Drug GMP Compliance Inspection” and mark the relevant dosage forms and production lines in the copy of the “Drug Production License” as “for export only” or “for export.” Any products manufactured outside the registered addresses, workshops, or production lines specified in the Drug Production License shall not be exported under the name of the drug production enterprise.
Furthermore, the regulations stipulate that export drugs not approved for marketing within China are prohibited from being sold or used within the country. Pharmaceutical manufacturers are also responsible for quality management during the storage and transportation of exported drugs within China. Export drugs produced on behalf of overseas pharmaceutical manufacturers are not allowed to be sold or used within China. Overseas manufacturers must directly sign commission and quality agreements with domestic production enterprises, and both parties must adhere to China’s drug management laws and regulations as well as those of the importing country or region, ensuring compliance with all quality responsibilities of drug GMP and continuous adherence to legal requirements.- Flcube.com
