Policies have been issued in many places to support the development of innovative drugs： Beijing proposes to speed up the examination and approval, and Guangzhou Development Zone (Huangpu District) fo
On April 17,Measures for Beijing to Support the High-quality Development of Innovative Medicine (2024).(hereinafter referred to as the "measures") released to the outside world.
The "Measures" mentioned that it will help accelerate the review and approval of innovative medical equipment. Promote the implementation of the national innovation pilot "the time limit for the review of drug supplementary applications has been reduced from 200 days to 60 days, and the time limit for the approval of drug clinical trials has been reduced from 60 days to 30 days".
National business daily reporter noted that since the beginning of this year, many documents supporting the high-quality development of innovative medicine and biomedicine have been issued to promote the rapid development of the pharmaceutical industry.
In April, the development of China’s pharmaceutical industry pressed the acceleration button. In addition to the above-mentioned Measures, on April 7, the Guangzhou Development Zone Management Committee and the Huangpu District People’s Government of Guangzhou issued the Measures for Guangzhou Development Zone (Huangpu District) to Promote the High-quality Development of Biomedical Industry. On April 1st, "Several Measures for Promoting the High-quality Development of Biomedical and Health Industry in Zhuhai (Draft for Comment)" was also released.
National business daily reporter found that the documents of Guangzhou Development Zone (Huangpu District) pay attention to giving full play to the role of financial encouragement. It is clearly stated in the document that for innovative drugs, improved new drugs and biologically similar drugs, if the R&D cost of clinical trials in China is more than 10 million yuan, according to their clinical R&D progress, the maximum funding will be 40% of the actual clinical R&D cost by stages: those who have completed phase I, II and III clinical trials will be given the maximum support of 10 million yuan, 20 million yuan and 30 million yuan respectively, and the maximum funding for a single enterprise will be given every year.
Zhuhai’s documents also involve financial encouragement in many places. For example, the document proposes that categories 1-2 of chemicals, biological products (except diagnostic reagents managed by drugs) and traditional Chinese medicine (innovative drugs of traditional Chinese medicine and improved new drugs of traditional Chinese medicine) should be rewarded according to the results of each stage of research and development. For the completion of phase I, II and III clinical trials (the completion of key clinical trials can be regarded as the completion of phase I, II or III clinical trials according to the actual situation), a one-time reward of up to 3 million yuan, 5 million yuan and 10 million yuan will be given respectively.
The "Measures" issued by Beijing this time proposed to speed up the examination and approval process. The Measures mentioned that,Promote the implementation of the national innovation pilot "the time limit for the review of drug supplementary applications has been reduced from 200 days to 60 days, and the time limit for the approval of drug clinical trials has been reduced from 60 days to 30 days".We will implement a key project-based management mechanism for innovative pharmaceutical enterprises, "one product, one policy", early intervention, and full guidance in registration and licensing. By the end of 2024, the cumulative number of varieties under project-based management will be raised to 200.
Wei Zining, Editor-in-Chief of Medical Reform and Dean of Management Development Research Institute of Beijing Sanyi Zhiku HospitalIn a telephone interview with national business daily, he said that the most direct effect of the Measures is to shorten the time for innovative drugs to go to clinic. This will enable innovative drugs to better serve patients.
Wei Zining said that measures such as "one product and one policy" and early intervention have strengthened communication with enterprises and promoted the high-quality development of biomedicine. Accelerating the development of innovative drugs can solve the pain points of people’s livelihood, and increasing the research and development of innovative drugs in China will also reduce the medical expenses of ordinary people.
The national business daily reporter found that the above three documents all mentioned supporting the development of innovative medicine.
The "Measures" put forward that efforts should be made to improve the quality and efficiency of clinical research of innovative medicine and to promote the clinical application of innovative medicine.
The document of Guangzhou Development Zone (Huangpu District) pointed out that the "new mode of collaborative supervision of biomedical provinces and regions" should be promoted, the leading role of national laboratories should be brought into play, and the establishment of the "research and examination linkage" mechanism for innovative drugs and innovative medical devices should be accelerated. Sort out the list of key development products such as innovative drugs and innovative medical devices in this area, actively promote the inclusion of the items in the list in the "triple" innovative service list of the Provincial Food and Drug Administration, and speed up the product listing process.
According to the document of Zhuhai City, those who get breakthrough therapy and conditional approval during the research and development of innovative drugs will be rewarded with another 1 million yuan. Encourage medical institutions to take the lead or participate in clinical trials, and shorten the research and development cycle of innovative medical equipment.
The reporter noted that this year’s government work report proposed to accelerate the development of frontier emerging industries such as hydrogen energy, new materials and innovative drugs.
Experts and business people are also highly concerned about topics related to innovative drugs.Bi Jingquan, Chairman of China International Economic Exchange CenterZeng said that the development of biomedical industry in China has a good foundation, and an ecological environment to encourage the development of innovative drugs is taking shape.
He suggested further deepening the understanding of the clinical value of innovative drugs, strengthening the basic research of life sciences, reforming the price formation mechanism of innovative drugs and the payment method of medical insurance, and studying and establishing the basic medical security system for the elderly.
During the two sessions of the National People’s Congress this year,Member Chinese People’s Political Consultative Conference, Vice Chairman of Zhejiang Provincial Committee of Agricultural Workers’ Party and Ding Lieming, Chairman and CEO of Beida Pharmaceutical Co., Ltd.It is believed that in view of the characteristics of great difficulty, long cycle and high investment in pharmaceutical R&D innovation, it is necessary to further enhance policy support and optimize the pricing of innovative drugs and medical insurance negotiations.
national business daily