It is estimated that half of the examination and approval time will be saved in the revision of the administrative measures for imported medicinal materials

[policies and regulations of pharmaceutical Station] on May 16, the State Administration of Market Supervision issued the measures for the administration of imported medicinal materials (Order No 9 of the General Administration, hereinafter referred to as the "measures") to revise and improve the measures for the administration of imported medicinal materials (Trial) (hereinafter referred to as the "Trial Measures") which has been implemented for more than ten years It is reported that the measures will be implemented from January 1, 2020 The power of examination and approval of imported medicinal materials will be delegated from the State Food and drug administration to the provincial drug administration, which is expected to save half of the examination and approval time Imported medicinal materials are an important part of Chinese medicinal materials resources, which play an important role in enriching domestic medicinal materials resources and ensuring people's medication and accessibility According to statistics, during the period of 2006-2013, there are 68 varieties of imported medicinal materials in China The actual total number of batches of imported medicinal materials is 3596, with a total value of US $270 million (about RMB 1.62 billion) Among them, Korean ginseng, Korean ginseng, American ginseng and other ginseng have a large number and large amount In recent years, the import of traditional Chinese medicine and decoction pieces has maintained a high trend In 2017, China imported 91000 tons of traditional Chinese medicine, an increase of 13.62% year on year; the total import value was 261 million US dollars, an increase of 29.69% year on year In 2018, imports totaled $285 million, up 9.16% year on year In addition, according to relevant personnel, since the 1990s, relevant departments have strengthened the supervision of imported medicinal materials and achieved positive results Relevant people said that after this revision, the import procedure of non imported medicinal materials will be greatly simplified The import unit will go directly to the Department of the drug regulatory department at the port location to handle the filing and receive the import drug customs clearance form "The import of traditional Chinese medicine is not the same as the import of chemical preparations and raw materials The unit price is low and the volume is large It is also affected by seasons and logistics If it is not properly preserved, it will rot and deteriorate It will be transported from the border to Beijing for inspection The time and economic cost are relatively high." Jin Hongyu, deputy director of the natural medicine department of the Institute for the inspection and determination of traditional Chinese medicine of CFDA, said that most of the companies engaged in the import of traditional Chinese medicine are small companies, and the implementation of the measures will save them time and cost in handling the approval documents After the implementation of the measures, it is expected that the examination and approval time for imported medicinal materials will be shortened to 20 working days, while for non imported medicinal materials, only the record is required In general, it can save at least half of the approval time for relevant enterprises So which drugs are non imported? According to the introduction, at present, China has issued two batches of catalogue of non imported drug varieties, 73 varieties are included The catalogue has clear regulations on the name, executive standard and origin of the medicinal materials, such as Glycyrrhiza in Kazakhstan and Dracaena in Malaysia In addition, the measures also fully take into account the special situation of ethnic minority medicinal materials The measures also stipulate that ethnic minority medicinal materials imported for local study in ethnic minority areas, if there is no national pharmaceutical standard, should conform to the corresponding provincial and autonomous regional pharmaceutical standards After the implementation of the measures, a unified information platform will also be established to improve the level of information technology, integrate multiple links such as examination and approval, filing, port inspection, etc., and publicize violations through the information platform to realize data sharing, intelligent supervision and social co governance.