National Drug Administration: Accelerated Evaluation of Innovative Drugs and Medical Devices

2023-07-07

On the 5th, the National People's Congress Office held a press conference on "Strengthening Drug Supervision and Effectively Ensuring the Safety of People's Medication". Jiao Hong, director of the National Medical Products Administration, revealed that up to now, China has approved 130 innovative drugs and 217 innovative medical devices. In the first half of this year alone, 24 innovative drugs have been approved for marketing, and a number of high-level drugs and equipment such as Rare disease drugs and domestic extracorporeal membrane oxygenation treatment products have been listed, effectively meeting the health needs of the people. Jiao Hong pointed out that in recent years, the State Food and Drug Administration has continuously deepened the reform of the drug and medical device review and approval system, continuously released policy dividends to encourage innovation in drug and medical devices, continuously improved the quality of drug and medical devices, and continuously enhanced the vitality of drug research and development innovation. China's drug and medical device innovation achievements have entered an explosive period. Jiao Hong said that with the introduction of the newly revised Measures for the Administration of Drug Registration and other supporting rules and documents, the number of drugs approved for marketing through the priority review procedure each year remained at more than 100, and the priority review resources have been increasing year by year to favor the registration application of new drugs with clinical advantages, drugs for children, and drugs for Rare disease, especially the development of a number of special guiding principles for children's drug use, The number of approved children's medication shows a significant upward trend, with a total of 66 children's medication approved in 2022. In the first half of this year, 46 children's medication varieties have completed technical evaluation work. Drug use for Rare disease has always been a concern of the society. Huang Guo, Deputy Director of the State Food and Drug Administration, said that the use of drugs for Rare disease is an indispensable life-saving drug. Since 2018, the State Food and Drug Administration has established a special channel for the review and approval of new drugs in clinical urgent need abroad, including the use of drugs for Rare disease, and has implemented a separate queue, encouraged the declaration, and accelerated the review. According to this policy, 23 new drugs for Rare disease have been approved for import and marketing through special channels. By 2020, new drugs for Rare disease with obvious clinical value will be included in the priority review and approval procedures. At present, among all drug marketing applications, the time limit for review and approval of new drugs for Rare disease is the shortest. Jiao Hong said that China will continue to optimize and improve the approval of clinically urgently needed drugs, Rare disease drugs, children's drugs, "choking" products, and promote the listing of a number of landmark innovative drugs with high technology, good efficacy, and great impact. According to reports, the State Food and Drug Administration has also promoted the establishment of a technical evaluation standard system that conforms to the characteristics of traditional Chinese medicine, approved 31 new traditional Chinese medicines, and helped traditional Chinese medicine inherit the essence, maintain integrity and innovate. At the same time, we have solidly promoted the consistency evaluation of generic drug quality and efficacy, with a total of 615 varieties passing the consistency evaluation, further meeting the medication needs of the people. (Reporter Fu Lili)

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