Measures for the Administration of Imported Medicinal Materials

For purposes of strengthening the supervision and administration of imported medicinal materials and guaranteeing the quality of imported medicinal materials, these Measures are enacted.
These Measures make provisions for the application for, the examination, approval, record filing, port inspection, supervision and administration of imported medicinal materials. Medicinal materials shall be imported via the ports permitting the import of drugs or the border ports permitting the import of medicinal materials as approved by the State Council (Art. 3). Importers of medicinal materials shall include marketing license holders of Chinese patent medicines, traditional Chinese medicine (“TCM”) producers, and business operators of TCM decoction pieces (Art. 5). The National Medical Products Administration shall be responsible for the supervision and administration of imported medicinal materials throughout the country. The NMPA shall authorize the medical products administrations in the provinces, autonomous regions and municipalities directly under the Central Government to conduct examination on and grant approval to the initial import of medicinal materials, and supervise and guide the authorized examination and approval activities.
In addition, according to Article 19, an importing entity shall file a record with the port drug supervision and management department, and submit the following materials: （1） Copy of certificate of origin; （2） Medicinal material standards and standard sources; （3） If the import of medicinal materials involves endangered wild animals and plants whose import and export are restricted by the Convention on International Trade in Endangered Species of Wild Fauna and Flora, a copy of the import and export permission certificate issued by the National Endangered Species Import and Export Administration shall also be provided; etc.