Quoted from: Dasu network
Xinhuanet Beijing, November 4th (Reporter Wang Sibei, Hu Hao) The 17th meeting of the 12th National People's Congress Standing Committee on the 4th, authorized the State Council in Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, and Sichuan provinces and cities have launched a three-year pilot program for drug listing and licensing.
"The drug listing license holder system is a drug management system generally implemented in the international community today." Xu Jinghe, director of the Legal Department of the State Food and Drug Administration, said that at present, China's Drug Administration Law stipulates that only pharmaceutical manufacturers can apply for drug registration. Obtain the drug approval number. With the rapid development of China's pharmaceutical industry and the continuous advancement of the drug regulatory concept system, the drawbacks of this product registration and production license bundled management system gradually emerged, which is not conducive to encouraging drug innovation and resource allocation.
The “Decision on Authorizing the State Council to Launch the Drug Listing Permit Holder System and Relevant Issues in Some Places”, which was voted on the 4th, clearly stipulates that the drug research and development institutions and scientific research personnel in the pilot provinces and cities can obtain the drug approval number and bear the corresponding quality of the drugs. responsibility.
Xu Jinghe said that the implementation of the drug listing permit holder system allows the drug listing license holder to be separated from the production enterprise, which is conducive to fully mobilizing the enthusiasm of the developers, promoting drug innovation; optimizing resource allocation, inhibiting low-level redundant construction; Main responsibility, strengthen drug quality management, improve drug quality; Innovate drug management mechanism, give full play to the role of government, enterprises and market in strengthening drug management.
In order to improve the quality of medicines and promote the transformation and upgrading of China's pharmaceutical industry, it was decided to also agree to the State Council to organize the reform of drug registration classification. According to the relevant provisions of the Drug Administration Law, the approval of the production of drugs with existing national drug standards shall comply with the national drug standards and achieve the quality and efficacy of the original drugs; approval of the production of drugs that have been listed in the country that have not been listed in the country, and no national drug standards. The quality and efficacy of the original drug should be achieved.
"Pharmaceuticals are directly related to the health and safety of the people. The implementation of the drug listing permit holder system is an important innovation in the drug regulatory system, which involves the improvement of relevant systems in the Drug Administration Law." Xu Jinghe said that in order to actively and steadily advance It is advisable to conduct pilot projects first, and after the practice proves feasible, it will be fully pushed forward. Through these pilots, we will accumulate experience and provide experience for further improvement of the next drug management law.
It is reported that the decision will take effect on November 5, 2015. The drug approval number obtained during the pilot period will continue to be valid after the expiration of the pilot period. During the pilot period, the State Council will strengthen the organization, guidance, supervision and inspection of the pilot work to ensure the quality and safety of drugs.