Wang Ping, State Drug Administration: the review of drugs for rare diseases should be completed within 3 months

On March 23, the economic summit of "China Development Forum 2019" hosted by the development research center of the State Council was held in Beijing Wang Ping, director of the Department of drug registration and administration of the State Drug Administration, delivered a speech at the session of "Dispelling the fog of drug use" Wang Ping said that in recent years, with the joint efforts of colleagues from all walks of life, the State Food and drug administration, in accordance with the unified deployment and requirements of the Central Committee, has taken a series of measures to deepen the reform of the review and approval system, strive to create a good atmosphere to encourage innovation, and strive to make new and good drugs at home and abroad come together in the hands of patients at home in the shortest time Wang Ping said that the State Food and drug administration has established a special evaluation mechanism for overseas new drugs that are urgently needed in clinical practice, and selected the first batch of 48 varieties that are urgently needed in clinical practice, including drugs for treatment of rare diseases and some drugs for treatment of serious life-threatening diseases The approval time for drugs for treatment of rare diseases is within three months, and for other urgently needed drugs is within six months He said that this year, the State Food and Drug Administration will further implement the requirements of the Central Committee for deepening reform, especially in cooperation with the Ministry of justice and the National People's Congress in promoting the amendment to the drug administration law After the determination of the drug administration law, the State Food and Drug Administration will immediately revise the drug registration management measures, and consolidate some mature experience gained by the State Food and Drug Administration in the early stage into the measures to ensure the stable development of the approval work Wang Ping stressed in the end that the State Food and Drug Administration will strengthen the R & D guidance for the declared enterprises, strengthen the coordination work in all aspects, strengthen the supervision work after the drug is put on the market, prevent and resolve major risks, effectively implement the main responsibility of the enterprise, and further strengthen the inspection work of drug data, such as the monitoring of adverse reactions of drugs, in general, it is necessary to resolutely Keep the bottom line of drug quality and safeguard the drug safety of the public.