Opinions of the General Office of the State Council on Reforming and Improving Policies on the Guaranteed Supply and Use of Generic Drugs
Opinions of the General Office of the State Council on Reforming and Improving Policies on the Guaranteed Supply and Use of Generic Drugs
Opinions of the General Office of the State Council on Reforming and Improving Policies on the Guaranteed Supply and Use of Generic Drugs
Guo Ban Fa [2018] No.20
March 21, 2018
People's governments of all provinces, autonomous regions and municipalities directly under the Central Government, all ministries and commissions under the State Council, and all institutions directly affiliated to the State Council,
For the purpose of implementing guidelines proposed at the 19th National Congress of the Communist Party of China (CPC) and arrangements made by the CPC Central Committee and the State Council on advancing the construction of a healthy China and deepening medical reform, promoting the research and development of generic drugs, boosting the quality and efficacy of generic drugs, enhancing the capability of guaranteeing the supply of drugs, better satisfying demands for drugs in clinical treatment and public sanitary safety, and accelerating China's transformation from a major pharmacy country into a pharmacy power, the following opinions are hereby proposed upon approval of the State Council.
I. Promoting the Research and Development of Generic Drugs
1. Design a directory of drugs, the imitation of which is encouraged. Create a mechanism to share information about the production and use of drugs across departments, strengthen the guaranteed supply of pharmaceuticals and the monitoring of the use thereof, gather and publish prompt information on the supply of drugs, and guide enterprises' research and development, registration and production. With the focus on demands, encourage the imitation of drugs that are indispensable in clinic treatment, have definite efficacy and are in short supply, and endorse drugs necessary for preventing and curing serious infectious diseases and treating rare diseases, drugs needed to respond to unexpected public sanitary accidents, drugs used by children, and those for which no registration applications have been filed within a year before the expiry of patents thereof. The said directory of drugs, the imitation of which is encouraged, will be compiled by the National Health Commission and the China Drug and Food Administration in concert with relevant authorities, published regularly on the National Comprehensive Management Information Platform for Guaranteed Supply of Drugs and other related platforms, and be dynamically adjusted. Drugs newly approved for marketing or drugs passing the quality and efficacy consistency evaluation of generic drugs shall be included in the directory of drugs on the Chinese market which will be updated from time to time and made public in a timely manner.
2. Step up efforts to tackle key technical problems in generic drugs. Include research into key common technologies for major chemical pharmaceuticals and bio-drugs, listed in the directory of drugs the imitation of which is encouraged, in relevant science and technology plans of the State. Optimize the mechanism of production, education, research, clinical application and concerted innovation, establish an alliance specialized in overcoming key technical problems in generic drugs, give play to enterprises' leading role and the basic supporting functions of hospitals, research institutes and institutions of higher learning, strengthen the synergistic research and development of active pharmaceutical ingredients, pharmaceutical excipients, pharmaceutical packaging materials and pharmaceutical preparations, and facilitate the effective connection between the R&D chain and the industry chain of drugs. Take an active approach to introducing international advanced technologies and make improvements to such introduced technologies, once fully digested and absorbed.
3.
......
Guo Ban Fa [2018] No.20
March 21, 2018
People's governments of all provinces, autonomous regions and municipalities directly under the Central Government, all ministries and commissions under the State Council, and all institutions directly affiliated to the State Council,
For the purpose of implementing guidelines proposed at the 19th National Congress of the Communist Party of China (CPC) and arrangements made by the CPC Central Committee and the State Council on advancing the construction of a healthy China and deepening medical reform, promoting the research and development of generic drugs, boosting the quality and efficacy of generic drugs, enhancing the capability of guaranteeing the supply of drugs, better satisfying demands for drugs in clinical treatment and public sanitary safety, and accelerating China's transformation from a major pharmacy country into a pharmacy power, the following opinions are hereby proposed upon approval of the State Council.
I. Promoting the Research and Development of Generic Drugs
1. Design a directory of drugs, the imitation of which is encouraged. Create a mechanism to share information about the production and use of drugs across departments, strengthen the guaranteed supply of pharmaceuticals and the monitoring of the use thereof, gather and publish prompt information on the supply of drugs, and guide enterprises' research and development, registration and production. With the focus on demands, encourage the imitation of drugs that are indispensable in clinic treatment, have definite efficacy and are in short supply, and endorse drugs necessary for preventing and curing serious infectious diseases and treating rare diseases, drugs needed to respond to unexpected public sanitary accidents, drugs used by children, and those for which no registration applications have been filed within a year before the expiry of patents thereof. The said directory of drugs, the imitation of which is encouraged, will be compiled by the National Health Commission and the China Drug and Food Administration in concert with relevant authorities, published regularly on the National Comprehensive Management Information Platform for Guaranteed Supply of Drugs and other related platforms, and be dynamically adjusted. Drugs newly approved for marketing or drugs passing the quality and efficacy consistency evaluation of generic drugs shall be included in the directory of drugs on the Chinese market which will be updated from time to time and made public in a timely manner.
2. Step up efforts to tackle key technical problems in generic drugs. Include research into key common technologies for major chemical pharmaceuticals and bio-drugs, listed in the directory of drugs the imitation of which is encouraged, in relevant science and technology plans of the State. Optimize the mechanism of production, education, research, clinical application and concerted innovation, establish an alliance specialized in overcoming key technical problems in generic drugs, give play to enterprises' leading role and the basic supporting functions of hospitals, research institutes and institutions of higher learning, strengthen the synergistic research and development of active pharmaceutical ingredients, pharmaceutical excipients, pharmaceutical packaging materials and pharmaceutical preparations, and facilitate the effective connection between the R&D chain and the industry chain of drugs. Take an active approach to introducing international advanced technologies and make improvements to such introduced technologies, once fully digested and absorbed.
3.
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