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).<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n