On April 28, 2019, the State Administration for Market Regulation deliberated and approved the Measures for the Administration of Imported Medicinal Materials (the “Measures”), which will go into effect on January 1, 2020, and the Measures for the Administration of Imported Medicinal Materials (Trial Implementation) previously promulgated on November 24, 2005 will be abolished. The specific provisions of the new Measures are highlighted below:
1. Permitted medicinal materials for import
Imported medicinal materials should conform to the national pharmaceutical standards. Any varieties not included in the current version of the Chinese Pharmacopoeia shall be subject to the standards for imported medicinal materials; for those that are not included in the current version of the Chinese Pharmacopoeia nor the imported medicinal material standards shall be subject to other national pharmaceutical standards. If ethnic minority medicinal materials are imported from ethnic minority areas where such medicinal materials are habitually used in the absence of national pharmaceutical standards, they shall comply with the corresponding standards for medicinal materials in those provinces and autonomous regions.
2. Application and approval of the initial import
For the initial import of medicinal materials, the applicant shall complete the application form for imported medicinal materials on the National Medical Products Administration information system (the “Information System”) and submit the following information to the provincial pharmaceutical supervision and administration departments: (1) the application form for imported medicinal materials; (2) a copy of the applicant’s pharmaceutical manufacturing license or pharmaceutical business license; and if the applicant has authorization for putting Chinese traditional medicine on the market, a copy of relevant pharmaceutical approval documentation shall be provided; (3) a copy of the registration certificate of the exporter; (4) a copy of the purchase contract and its notarized documentation; (5) information on the ecological environment, resource reserve, wild or planted cultivation conditions, harvest and preliminary processing of the medicinal materials, of the location where the medicinal materials were manufactured; (6) standards for the medicinal materials and the sources of those standards; (7) an original authentication certificate for the origin of medicinal materials issued by a Chinese institution qualified to authenticate the animal and plant origin, with information such as the authentication basis, authentication conclusions, sample pictures, authenticator, authentication institution, and official seal.
The medicinal materials that are not considered as being imported for the first time shall be directly recorded with the port supervision and administration department in accordance with the Measures.
3. Import recordation
The applicant for the initial import of medicinal materials shall, within one year after obtaining approval for the imported medicinal materials, arrange for the importation of the medicinal materials from the port of arrival indicated in the approval document. The importing unit shall record with the port pharmaceutical supervision and administration department, fill in the inspection form for the imported medicinal materials on the Information System, and submit the following materials: (1) the original inspection form for the imported medicinal materials; (2) a copy of the certificate of origin; (3) the standards for the medicinal materials and the sources of those standards; (4) a copy of packing list, bill of lading and freight invoice; (5) a copy of all purchase contracts, packing lists, bills of lading and freight invoices from the place of origin to re-export areas, for imported medicinal materials that were re-exported from other countries (areas); and (6) if the imported medicinal materials involve endangered wild fauna and flora whose import and export are restricted under the Convention on International Trade in Endangered Species of Wild Fauna and Flora, a copy of the certificate issued by the competent authority for the import or export of endangered fauna and flora of the country shall be provided. In the case of recordation for the initial import of medicinal materials, except for materials stipulated in Subparagraph 1, it is also necessary to submit a copy of the approval document and the supplemental approval documents (if any) for the imported medicinal materials. For the recordation of medicinal materials that are not being imported for the first time, a copy of the pharmaceutical manufacturing license or pharmaceutical business license of the importing unit, a copy of the registration certificate of the exporter, and a copy of the purchase contract and its notarized document shall also be submitted. If the importing unit has authorization for putting Chinese traditional medicine on the market, a copy of relevant pharmaceutical approval certificates shall be provided.
4. Port inspection
The port drug supervision and inspection department shall conduct a review in form on the completeness and compliance of the recordation materials. If the requirements are met, a customs clearance form for imported pharmaceuticals will be issued upon recovery of the initial import approval documents. Meanwhile, a port inspection notice for imported medicinal materials will be issued to the port pharmaceutical inspection agency along with a copy of the recordation materials.
After receiving the port inspection notice for imported medicinal materials, the port pharmaceutical inspection agency shall, within 2 days, consult the importing unit to setup a time for conducting the on-site sampling and execute the on-site sampling at the specified storage location at such time. At the time of the on-site sampling, the importing unit shall produce the original certificate of origin.
In addition, to ensure the quality of imported medicinal materials, the Measures also stipulate the following methods. First, the standards for the medicinal materials should be strictly enforced. For varieties with different sources of origin, their standards should be enforced by the following order: the current version of the Chinese Pharmacopoeia, the standards for imported medicinal materials, and the standards promulgated by relevant authorities. For ethnic minority medicinal materials, the standards for medicinal materials in the corresponding provinces and autonomous regions may be enforced. Secondly, traceability management is enhanced by requiring imported medicinal materials to pass the port inspection before they can be put on the market. When imported medicinal materials are purchased and imported by pharmaceutical users and manufacturers, a copy of the inspection report issued by the port pharmaceutical inspection agency and a copy of the customs clearance form of indicating that “a sample has been taken” that is further affixed with a public seal shall be looked for in the strict implementation of the traceability management requirements. Thirdly, the level of informatization should be enhanced through a unified information platform, integration of multiple elements such as approvals, recordation and port inspection information to realize data sharing, smart supervision and disclosure of legal violations so as to achieve social co-governance.