The most comprehensive policy interpretation strategy of the measures for the administration of imported medicinal materials

1、 What kinds of medicinal materials can be applied for import? The medicinal materials to be imported shall be the varieties included in the current version of the Chinese Pharmacopoeia, the standards for imported medicinal materials and the standards issued by the Ministry At the same time, in order to ensure the drug demand of ethnic minority areas, ethnic minority medicinal materials that are not included in the national drug standards but are included in the corresponding provincial and autonomous regional drug standards can also be imported for local use 2、 What qualifications does the import unit of medicinal materials need to possess? The importer shall be the holder of the listing license of Chinese patent medicine, the manufacturer of Chinese traditional medicine, and the drug distributor with the business scope of Chinese traditional medicine or Chinese herbal pieces Considering that medicinal materials are different from preparations, there are special requirements for their storage and maintenance, so as to avoid mildew and moth, and the single import volume is usually large In order to ensure the quality of medicinal materials, pharmaceutical trading enterprises are required to have the business scope of Chinese medicinal materials or Chinese Herbal Pieces 3、 Which kinds of medicinal materials can be included in the catalogue of non first imported medicinal materials? During the trial implementation of the original measures for the administration of imported medicinal materials, the state drug regulatory authority has issued two batches of catalogue of non first imported medicinal materials, including 73 varieties, which include the name of medicinal materials, Executive Standards and the origin of medicinal materials, such as liquorice produced in Kazakhstan and Dracaena produced in Malaysia Next, SFDA will revise the catalogue in due time 4、 What are the first import procedures applicable? For the first import of varieties other than the catalogue of non first imported medicinal materials, the applicant shall declare according to the first import procedure When the product is imported from the country again, it shall be imported according to the non first import procedure However, other applicants are not allowed to "hitchhike", and the first time they import the variety from the country, they still need to declare according to the first import procedure The reason why the specific "applicant" is stipulated mainly includes the following considerations: the source of imported medicinal materials is generally the trade secret of the importing unit, and it is difficult for other applicants to find the same source of goods; secondly, the medicinal materials stress the origin and the authenticity, and the specific "applicant" can fix the source of goods, which is conducive to ensuring the quality of medicinal materials 5、 Which (border) ports can medicinal materials be imported for customs clearance? Medicinal materials shall be imported from the ports approved by the State Council to allow the import of pharmaceuticals or from the border ports to allow the import of medicinal materials At present, there are 22 drug import ports and 22 drug import border ports respectively According to their own needs, import units can choose corresponding (border) ports to handle import clearance 6、 How to handle the examination and approval of imported medicinal materials? In order to implement the reform requirements of "release and management service" and facilitate the applicants, the State Food and Drug Administration entrusts the provincial drug supervision and administration department to examine and approve the first import of medicinal materials The applicant shall apply for import to the local provincial drug supervision and administration department, and the local provincial drug inspection institution shall undertake the sample inspection For those that meet the requirements, one-off approval documents for imported medicinal materials shall be issued Simplify the import procedure of non first imported medicinal materials, and the import unit can directly handle the filing 7、 How to handle the filing of imported medicinal materials? For the first import of medicinal materials, the applicant shall, within one year after obtaining the approval document for imported medicinal materials, organize the import of medicinal materials from the port of arrival indicated in the approval document for imported medicinal materials For the first and non first import of medicinal materials, the importing unit shall handle the record of imported medicinal materials with the Department in charge of drug supervision and administration at the drug import port or the place where the drug import border port is located, and receive the import drug customs clearance form 8、 What is the port drug inspection agency? "Port drug inspection institution" in the administrative measures for imported medicinal materials refers to the provincial drug inspection institution in the place where the port or border port is located and the drug inspection institution determined by the State Food and drug administration 9、 How to handle the port inspection of imported medicinal materials? When handling the filing of imported medicinal materials, the importing unit may select the corresponding port drug inspection institution The port drug inspection agency shall, within the prescribed time, negotiate with the import unit on the spot sampling time 10、 How to ensure the quality of imported medicinal materials? The first is to strictly implement the standards for medicinal materials For varieties with different origins, the order of implementation of the standards is: current version of Chinese Pharmacopoeia, standards for imported medicinal materials, ministerial standards, etc The standards for ethnic minority medicinal materials may be implemented in the corresponding provinces and autonomous regions Second, strengthen the traceability management Imported medicinal materials can only be listed for circulation and use after passing the port inspection When purchasing imported medicinal materials, the drug users and producers shall check the copies of the inspection report of imported medicinal materials issued by the port drug inspection authorities and the copies of the customs clearance form of imported medicines marked "sampled" and stamped with the official seal, and strictly implement the relevant provisions of drug traceability management The third is to improve the level of information technology, through the establishment of a unified information platform, the integration of imported medicine examination and approval, filing, port inspection and other aspects of information, to achieve data sharing, intelligent supervision, and disclosure of violations, to achieve social co governance 11、 Can electronic declaration be realized in the future? In the design of information platform, the function of data upload has been considered to leave an interface for future electronic declaration However, considering that there are some difficulties in electronic declaration in some regions, after the information platform has been running for a period of time and all links have been well run in, electronic declaration will be gradually promoted to maximize the import of local medicines This article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.