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In order to promote the reform of the drug review and approval system, encourage drug innovation, improve drug quality, and provide practical experience for further reform and improvement of the drug management system, the 17th meeting of the Standing Committee of the 12th National People's Congress decided:
1. Authorize the State Council to carry out a pilot drug market licensing system in Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, Sichuan, ten provinces and municipalities directly under the Central Government.
, the State Council agreed to organize the reform of drug registration classification, improve the quality of drugs, and promote the transformation and upgrading of China's pharmaceutical industry. To this end, 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 that already have national drug standards shall conform to the national drug standards and meet the quality and efficacy of the drugs studied; The State Administration of Food and Drug Administration shall formulate and revise the relevant national drug standards in a timely manner in accordance with the above-mentioned requirements.
period authorized by this decision shall be three years, which shall be calculated from the date of the implementation of this decision. The State Administration of Food and Drug Administration shall formulate a specific pilot program and report it to the Standing Committee of the National People's Congress for the record after approval by the State Council. During the pilot period, the State Council should strengthen the organization guidance and supervision and inspection of the pilot work to ensure the quality and safety of medicines. After the end of the pilot period, if the practice proves feasible, the Drug Administration Law of the People's Republic of China shall be amended and perfected, and if the practice proves that it is not appropriate to adjust, the provisions of the Drug Administration Law of the People's Republic of China shall be reinsted out. Drug approval numbers obtained during the pilot period will continue to be valid after the end of the pilot period. Before the expiration of the pilot period, the State Council shall present a report on the implementation of this decision to the Standing Committee of the National People's Congress.
this decision will take effect on November 5, 2015. (State Administration of Food and Drug Administration)