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Business News October 13th

In order to make the supervision and management of imported medicinal materials more scientific and rigorous, the CFDA organized a revision of the "Administrative Measures for Imported Medicinal Materials (Trial)" and drafted the "Administrative Measures for Imported Medicinal Materials (Revised Draft)", which will solicit public opinions before October 20.

Management history

At the end of the 1980s, the former national health department made it clear that the licensing system for imported medicinal materials was not temporarily implemented; in the 1990s, the "Imported Drug Administration Measures" were promulgated, and it was decided to implement a registration management system for imported medicinal materials. The annex is promulgated. At the beginning of this century, the national food and drug regulatory department listed the management of imported medicinal materials separately from the "Measures for the Administration of Imported Medicines" and formulated the "Administrative Measures for Imported Medicinal Materials (Trial)." The revised manuscript we see now is a revision that keeps pace with the times on the basis of the trial manuscript that year.

Revision background

The current government has put forward the goal of reducing administrative approval items and promoting the disclosure of administrative approval. It aims to open the door to reform, listen to the opinions of all parties in the society, and further promote the reform of the administrative approval system in a more targeted manner, and further streamline administration and delegate powers. By the beginning of 2015, the original target had been achieved, but the national level did not stop the work, and continued to promote the reduction and decentralization of administrative approval projects. When the "Opinions on Reforming the Review and Approval System of Drugs and Medical Devices" (Guofa﹝2015﹞44) was issued, the industry believed that it is not common for the State Council to make a decision on the reform of the administrative examination and approval system of a department, which fully reflects the state’s , Pay attention to the administrative examination and approval of medical devices. The current revision of the "Administrative Measures for Imported Medicinal Materials (Trial)" can also be regarded as a specific task for the competent authority to implement the spirit of the State Council's administrative examination and approval reform.

The main content of the revision

Part of the approval authority has been delegated, that is, the approval of non-first imported medicinal materials is delegated to the provincial food and drug supervision and administration department; the overseas inspection of the production site of imported medicinal materials is increased, that is, the provincial food and drug supervision and administration department at the port or border port can, according to needs, Conduct overseas inspections on the production sites of imported medicinal materials. Here, the production site should include planting, breeding, and processing sites to confirm the reliability of the supply chain. At the same time, the introduction of market inspection of imported medicinal materials will be added, and the dual insurance of port inspection and market inspection shall be implemented for imported medicinal materials.

Generally speaking, the management of imported medicinal materials has become more stringent, reflecting the trend of establishing a management model of “wide approval and strict supervision”. However, from the perspective of reducing administrative examination and approval matters, it is more reasonable to transfer non-first imported medicinal materials to the provincial food and drug supervision and administration department without reducing administrative examination and approval. Is it more reasonable to change to a filing system? Because the revised draft adds a listing inspection and on-site inspection system, which constitutes multiple quality insurance with the original port inspection system, it has the conditions to reduce the approval of non-first imported medicinal materials to the end. Another thing to note is that some medicinal materials are agricultural and sideline products, that is, they can be imported in accordance with agricultural and sideline products management regulations and then flow into the medicinal material market, which means that it is possible to choose one of the two management systems that is more relaxed and applicable. Under the dual inspection scenario, can pharmaceutical factories and decoction pieces factories exempt imported medicinal materials from entering the factory? It can also be discussed.

'S influence on Chinese patent medicine preparations

According to the statistics of the name of the 66 non-first-time imported medicinal materials published by the state, there are 6,300 existing Chinese patent medicine prescriptions, and 3385 imported medicinal materials may be used in the relevant prescriptions, accounting for 54% of the total Chinese patent medicine prescriptions. There are 14 kinds of medicinal materials used in hundreds of prescriptions, 17 kinds of medicinal materials are used in 30 to 99 prescriptions, 29 kinds of medicinal materials are used in 1 to 27 prescriptions, and 6 kinds of medicinal materials are used in Chinese patent medicine prescriptions. Not used.

Licorice is the most widely used, reaching 1649 prescriptions. The frequency of using imported medicinal materials in 300-500 prescriptions is: Schisandra, Cinnamon, Parsnip, Frankincense, Myrrh, Clove. Among the non-first imported medicinal materials, some medicinal materials are traditional imported medicinal materials (such as frankincense, myrrh, coptis, etc.), some are domestic and imported medicinal materials (such as licorice, cork, parsnip, etc.), and some are ethnic medicines (such as India) Roe sprouts, Tibetan madder, big stipule Yunshi, etc.), some of which are formula medicinal materials (such as Korean red ginseng, Korean red ginseng, etc.). The quality difference between imported medicinal materials and domestic medicinal materials, the quality differences of different exporting countries (some imported medicinal materials exporting countries cover Europe, Africa, and Asia), the application of standards for imported medicinal materials, the relationship between imported medicinal materials standards and the Chinese Pharmacopoeia, imports It is necessary to further refine and clarify the approval of medicinal materials and the disclosure of inspection information.

(Source: Pharmaceutical Economic News)