"Administrative measures for imported medicinal materials" released! Import process will be simplified

[industry trends of pharmaceutical Station] recently, the State Administration of market supervision and Administration issued the revised Measures for the administration of imported medicinal materials (hereinafter referred to as the measures), which further tightened the administration of imported medicinal materials to ensure the quality and safety of imported medicinal materials The measures shall be implemented as of January 1, 2020, including 35 articles in 7 chapters In terms of management of imported medicinal materials, classified management shall be implemented for imported and non imported medicinal materials Imported medicinal materials are an important part of Chinese medicinal resources, and their quantity and quality affect the development of Chinese medicinal materials market Compared with the original measures for the administration of imported medicinal materials (for Trial Implementation), the measures abolished the restriction that "the border port that allows the import of medicinal materials can only import the medicinal materials produced by the countries or regions around the port", and encouraged more medicinal materials to be imported We will be stricter in the implementation of standards for imported medicinal materials According to the interpretation of the industry, the imported medicinal materials should have the national pharmaceutical standards, including the current version of the Chinese Pharmacopoeia, the standards for imported medicinal materials and the ministerial standards For varieties with different sources of standards, the order of implementation of the standards is the current version of Chinese Pharmacopoeia, standards for imported medicinal materials and ministerial standards At the same time, it is considered that traditional ethnic minority medicines such as Uygur Medicine and Tibetan medicine are mostly dependent on imported medicinal materials In order to ensure the use of medicine in ethnic minority areas, it is required to import ethnic minority medicinal materials that are commonly used in ethnic minority areas If there is no national pharmaceutical standard, it shall meet the corresponding provincial and autonomous regional pharmaceutical standards The measures require the classified management of imported medicinal materials, and entrust the examination and approval of imported medicinal materials to the provincial drug supervision and administration department where the applicant is located The sample inspection originally undertaken by CFDA shall be adjusted to the provincial drug inspection institution accordingly According to the risk level, the import management of non imported medicinal materials is simplified The import unit can directly handle the filing and receive the import drug customs clearance form This is also a bright spot of the measures, which is conducive to greatly reducing the examination and approval time of imported medicinal materials It is reported that after the implementation of the measures, the approval time for imported medicinal materials will be shortened by 20 working days In addition, it emphasizes to strengthen supervision and traceability management It is required to further clarify the requirements that imported medicinal materials can be marketed and used only after passing the port inspection; when purchasing imported medicinal materials, it is required to ask the supplier for relevant supporting materials and strictly implement the relevant provisions on drug traceability management; at the same time, it is required that the acceptance of the application for import of medicinal materials, the results of examination and approval, the circumstances of relevant violations and penalties shall be subject to the State Drug Administration The Department website is open According to the industry, the quantity and quality of imported medicinal materials affect the development of China's traditional Chinese medicine market In recent years, the quantity and types of imported medicinal materials in China are increasing, and the value of goods is constantly reaching a new high According to statistics, during the period of 2006-2013, there were 68 varieties of imported medicinal materials in China The actual total number of imported medicinal materials was 3596, the total amount of goods was 79968.1 tons, and the total value of goods was about 1.62 billion According to the 2017 analysis report on the circulation market of traditional Chinese Medicine issued by the Ministry of Commerce, in 2017, China imported 91000 tons of traditional Chinese medicine, an increase of 13.62% year-on-year The total import of traditional Chinese medicine was 261 million US dollars, an increase of 29.69% year-on-year, far higher than the year-on-year growth of 18.7% of China's import of goods Among them, Korean ginseng, Korean ginseng and American ginseng are more The measures comprehensively implement the reform requirements of "release, management and service", which is conducive to the management of imported medicinal materials and ensure the quality and safety of imported medicinal materials In addition, with the shortening of import approval time, it is good news for the trade of Chinese medicinal materials, pharmaceutical enterprises and the common people.