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The first batch of medical institutions in Hebei Province to adjust the list of preparations

Time: 2017-05-05 

Source: Chinese Medicine News Author: Shen Tian Yanxun positive first

      (Reporter Shen Zhengxian correspondent Tian Yanxun) Recently, the Hebei Provincial Food and Drug Administration officially issued "on the publication of the first batch of Hebei Province, medical institutions to adjust the list of preparations," to determine the 432 kinds of traditional Chinese medicine preparations in the province of medical institutions to adjust the use of , Of which 310 public medical institutions, 122 private medical institutions.

      Medical institutions as a long-term clinical practice of medical institutions to test the results, not only the medical institutions of traditional Chinese medicine advantages of an important carrier, but also the source of Chinese medicine to create new drugs. For a long time, traditional Chinese medicine preparations in accordance with the management of chemical drugs, has always been difficult to declare difficult, difficult to use, easy to use and other issues, streamlining declarations, simplified reporting procedures, release swap use, in accordance with the laws of Chinese medicine management of traditional Chinese medicine preparations more and more high The

      To crack this shackles, Hebei Province, the Chinese Medicine Authority as actively, take the initiative to strengthen and Hebei Province Food and Drug Administration communication and coordination. In particular, in 2016 held in Hebei Province People's Congress Standing Committee to listen to the "Development of Chinese Medicine Regulations in Hebei Province," the implementation of the report, the traditional Chinese medicine as a special task for supervision, to promote the relevant departments to strengthen awareness and attention to speed up the pace of policy The Subsequently, in Hebei Province, the Chinese Medicine Administration of the fight, "the CPC Hebei Provincial People's Government of Hebei Province on the further deepening of the comprehensive reform of public hospitals guidance" clearly stipulates: reform of medical institutions of traditional Chinese medicine preparation approval, production, use management, selection Effective, excellent prices, the application of a wide range of medical institutions in the province's medical institutions in circulation.

      In order to ensure the implementation of the policy, the Hebei Provincial Traditional Chinese Medicine Administration Joint Provincial Food and Drug Administration organized a symposium on hospital representatives, in-depth study of the feasibility of medical institutions to adjust the use of agents. October 2016, Hebei Province Food and Drug Administration issued a "selection on the use of medical institutions to adjust the variety of traditional Chinese medicine preparations notice" to carry out the relevant preparatory work, and actively implement the provincial government decision-making, medical institutions, The use took a substantial step forward. The Hebei were selected a total of 432 kinds of traditional Chinese medicine preparations in the province to adjust the use of medical institutions, including 310 public medical institutions (262 kinds of Chinese medicine, public comprehensive and specialist hospitals 48), 122 private medical institutions. These preparations are selected by expert review, with toxic side effects, clinical efficacy of good features.

      It is clear that since April 25, 2017, the variety of units within the catalog can be submitted to the local municipal food and drug regulatory authorities to adjust the use of the application, explain the reasons for use, duration, quantity and scope, with the consent of the use of units will Review and related materials are submitted together with the consent of the City Council where the use unit is located. In other words, the use of medical institutions to adjust the use of the need to supply and demand side of the municipal food and Drug Administration's double consent.

      The medical institution that obtains the preparation number shall be responsible for the quality of the preparation of the medical institution used for the preparation and shall be trained and recorded on the use method and precautions to the medical institution using the preparation before use. The medical institutions that accept the adjustment shall use the preparations in strict accordance with the instructions of the preparation and bear the responsibility for the adverse consequences caused by the use or improper use of the super-scope. The Municipal Food and Drug Administration and the Provincial Food and Drug Administration shall revoke its approval documents and cancel their decentralization authority in accordance with the relevant provisions of the Municipal Food and Drug Administration, which does not follow the prescribed procedures and requirements for examination and approval of the use of pharmaceutical preparations and causes serious consequences. responsibility. Municipal Food and Drug Administration to adjust the preparation of regulatory equipment, the suspension of the use of substandard products, the development of serious adverse reactions to the use of the termination of the swap.

      Notification requirements, each approved the use of a unified period of not more than 12 months, due to continue to use the swap, should be submitted again in advance to apply.