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    Home > Active Ingredient News > Drugs Articles > Decision of the Standing Committee of the National People's Congress on Authorizing the State Council to carry out pilot drug listing license holder system in some places and relevant issues

    Decision of the Standing Committee of the National People's Congress on Authorizing the State Council to carry out pilot drug listing license holder system in some places and relevant issues

    • Last Update: 2015-11-05
    • Source: Internet
    • Author: User
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    Source: Xinhua news agency, Nov 4, 2015 Xinhua news agency, Beijing, Nov 4 - decision of the Standing Committee of the National People's Congress on Authorizing the State Council to carry out pilot drug listing license holder system in some places and relevant issues (adopted at the 17th meeting of the Standing Committee of the 12th National people's Congress on Nov 4, 2015) In order to promote the reform of drug review and approval system, encourage drug innovation, improve drug quality, and provide practical experience for further reform and improvement of drug management system, the Standing Committee of the 12th National People's Congress decided at its 17th Meeting: 1、 The State Council is authorized to carry out pilot drug listing license holder system in ten provinces and municipalities directly under the central government in Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan, to allow drug research and development institutions and researchers to obtain drug approval numbers and bear corresponding responsibilities for drug quality 2、 We agree that the State Council will organize the reform of drug registration and classification, improve the quality of drugs, and promote the transformation and upgrading of China's drug industry Therefore, in accordance with the relevant provisions of the drug administration law of the people's Republic of China, the approval of the production of drugs with the existing national drug standards shall meet the national drug standards and reach the quality and efficacy of the original drugs; the approval of the production of drugs that have been listed in the domestic market but have not yet reached the national drug standards shall reach the quality and efficacy of the original drugs The State Food and drug administration shall, in accordance with the above requirements, formulate and revise relevant national drug standards in a timely manner The pilot period authorized by this decision is three years, counting from the date of implementation of this decision The State Food and drug administration shall formulate specific pilot programs, which shall be submitted to the Standing Committee of the National People's Congress for the record after being approved by the State Council During the pilot period, the State Council shall strengthen the organization, guidance, supervision and inspection of the pilot work to ensure the quality and safety of drugs After the expiration of the pilot period, if the practice proves feasible, the drug administration law of the people's Republic of China shall be revised and perfected; if the practice proves that it is not suitable to adjust, the provisions of the drug administration law of the people's Republic of China shall be resumed The drug approval number obtained during the pilot period shall continue to be valid after the expiration of the pilot period Before the expiration of the pilot period, the State Council shall submit a report on the implementation of this decision to the Standing Committee of the National People's Congress This decision shall come into force as of November 5, 2015.
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