The state department's deployment to accelerate the drug review and generic medicines spring approach

　　The state Council has issued the national drug safety plan of the 13th five-year plan ( hereinafter referred to as the " planning" ), and deployed the relevant work to strengthen drug control and improve the quality and safety of drugs within the next five years. " Planning" proposed that by 2020, to achieve the drug quality safety level, drug safety governance capacity, the development of the pharmaceutical industry and the people's satisfaction improved significantly.

　　The plan provides detailed deployment of actions related to drug, medical devices and cosmetic standards, and proposes to deepen the review and approval system reform of drug medical devices to accelerate the quality and efficacy of generic drugs. According to the requirements of the state Council, to achieve the balance of the application for registration and the number of annual turnover in the examination as soon as possible, and to examine and approve in accordance with the specified time limit, and solve the backlog of drug registration application.

　　At the same time, the plan emphasizes once again, encouraging the listing of new drugs, generic drugs with significant clinical value and clinically urgent needs, and giving priority to review and approval. To encourage clinical institutions and doctors to participate in the research and development of innovative drugs and medical devices, and to give priority to the examination and approval of innovative medical devices with the core technology of products, major clinical value and clinical need for medical devices.

　　It is understood that since the beginning of 2017, the government has issued the relevant policy documents such as " deepening the medical and health system reform plan of the 13th five-year plan" and " several opinions on the further reform and improvement of the policies of drug production and circulation utilization ", and put forth efforts to promote the deepening of China's medical system reform. Among them, the acceleration of drug consistency evaluation always attaches great importance, and the first time reference to the " mutual substitution of drug directory with the original research drug ", which indicates that the support of the policy for the consistency evaluation of generic drugs has risen to a new level.

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