According to the news from the website of Chinese Government (www.gov.cn), the State Council of China released “the 12th 5-year Planning of National Drug Safety” (shorted as “the planning”) lately. The planning indicated that a completed drug manufacturing and supply system had taken shape in China during the 11th 5-year-plan period, a drug safety supervision system covering the whole process of research and development, manufacturing, circulation and usage has also been established, which greatly helped to improve the drug safety condition and the ability of drug safety control.
In the first part of the planning, it indicated the current drug safety condition and pointed out that the overall passing rate of drug evaluation sampling around the country had been significantly raised, especially the passing rate of chemical drugs, TCM, biological products, which showed that Chinese overall drug quality level was good. Since the implementation of “Drug Registration Management Measures (2007)”, new drug application, examination and approval standards has been promoted, drug manufacturing approval has been more stringent, the quality of new launched generic drugs has significantly improved. By means of enhancing adverse drug reaction monitoring and more usage of the early warning function of the special drug abuse monitoring network, China has greatly improved its ability of handling drug safety contingency, and has reduced drug safety accidents.
Meanwhile, with the implementation of national essential drug system, the improvement of new drug innovation ability, the steady construction of modern drug logistic system, and the completion of drug supply network covering the rural and urban area, the drug demand of the public has been basically fulfilled and the fundamental right of drug usage has also been insured. National drug reserve system has been established, which promoted the drug supply capacity to major epidemics and disasters.
During the 11th 5-year-plan period, Chinese drug safety supervision ability has been greatly improved. A complete 4-level authority (national, provincial, municipal and county) supervision system has been established. Technical support system, focused on drug registration assessment and evaluation, standard establishment, inspection and examination and adverse reaction monitoring, has been built. National law and regulation system has been more completed, which takes “Drug Administration Law of the P.R.C.” and “Regulation on the Supervision and Management of Medical Equipments” as the cores. National drug related standards management system has been formed, which takes “Pharmacopeia of the P.R.C.” as the core. The construction of drug supervision information system has made progress. Drug quality management regulations have been improved, whole process supervision has been enhanced. The process of electronic supervision of special drugs had been smoothly promoted. Infrastructure of drug administration has been significantly improved; the talent of the authority staff has also further improved.
Date: Feb. 13th, 2012