For a long time, it is not only the funding problem that restricts the innovation of new drug research and pharmaceutical enterprises in China. What is more important is the relative lag of drug review and approval. For example, the time for clinical trial approval often has to wait for 10 months or even longer. Missing waiting in waiting. The "Opinions" have made many major adjustments to the shortcomings of the previous review and approval system, including clinical trials, to crack the bottleneck of innovation in China's pharmaceutical industry.
Dr. Li Youxin, President of Global R&D of Luye Pharmaceutical Group, analyzed the significance of the subversive reform of the Opinions from the perspective of new drug research and development and generic drug production. Innovative medicine, reforming clinical trial management, clinical trial approval from past explicit permission to implied permission, enhancing the predictability of clinical trial approval; improving the efficiency of clinical trial application ethics review, is conducive to ensuring the rationality of the program and The quality of clinical trials; in the case of generic drugs, the establishment of a list of listed drugs, listing the patent rights of the imitation objects and the protection period of the test data, etc., not only for the imitation of the imitation of the object, but also for the generic formulation of the generic drug And reporting strategies.
In order to supplement the shortcomings of insufficient resources in clinical trial institutions, the Opinions changed the qualification system of clinical trial institutions to record management, and proposed to encourage clinical trials, improve ethical mechanisms, improve examination efficiency, optimize processes, and accept data from overseas clinical trials. A series of measures. In particular, it encourages social forces to invest in the establishment of clinical trial institutions, and also allows overseas enterprises and scientific research institutions to simultaneously conduct clinical trials of new drugs in China. These regulations will not only speed up the examination and approval of clinical trials, but also “unbundle†the investment of social funds and foreign institutions in this field.
Xu Yanjun, deputy general manager of Changchun Baike Quality, believes that the "Opinions" also solve the bottleneck problem affecting the efficiency of review and approval. In particular, the priority review and approval policy will allow powerful pharmaceutical companies to focus on superior resources to research and develop a new class of drugs, which will help new drugs enter the market faster.
In addition, the "Opinions" canceled the examination and approval of raw materials, pharmaceutical excipients, packaging materials, etc., and approved the approval of the preparations, making the approval process more concise and reasonable, and will stimulate the innovation vitality of enterprises.
Boosting companies to the international market
Bi Jingquan, director of the State Food and Drug Administration, pointed out at the video conference held on October 10 that deepening reform and encouraging innovation is the need to promote the supply-side structural reform of the pharmaceutical industry and realize the national strategy of innovation-driven development. “Innovation†is at the top of the five development concepts. Since the 18th National Congress of the Communist Party of China, the policy environment and institutional environment for drug innovation have undergone great changes. The introduction of the "Opinions" has brought unprecedented historical development opportunities to promote the structural adjustment and technological innovation of China's pharmaceutical medical device industry.
China's pharmaceutical innovation capacity is weak, and some of the limited new chemical drugs and biological products are mostly imitations of foreign-originated drugs. In view of this, the Opinions have established an exclusive incentive policy for promoting the development of pharmaceutical innovation and generic drugs. Such as supporting the clinical application of new drugs, promoting the imitation of pharmaceutical production, and promoting the full implementation of the system for listing license holders. According to Yang Junbin, director of the Registration and Control Division of Drugs, Cosmetics and Medical Devices of the Food and Drug Administration of Hainan Province, the system of listing license holders is a major positive for researchers and entrepreneurs. “The 'gold content' is very high. The implementation of this system can allow medical research institutions or individuals to concentrate on innovation, responsible for research and development of good medicines, and let pharmaceutical companies concentrate on making good medicines. This is a major breakthrough, representing the registration system of Chinese medicines. The 'bundling system' of the marketing license and the production license, the system of separation between the marketing license and the production license." Yang Junbin said.
Innovation is an indispensable material and technical support for building a healthy China. It also has the need for industrial restructuring, technological progress and sustainable development. The system of listing license holders is also a popular system for international medical supervision, which has a positive effect on drug innovation, production and supervision.
The "Opinions" also require all localities and departments to support drug innovation as an important part of building an innovative country and promoting the development of high-tech industries. It can be seen that the "Opinions" is not only a deepening of the reform of the drug and plastics review and approval system, but also can effectively optimize the allocation of industrial resources, promote industrial upgrading, thereby enhancing the international competitiveness of China's pharmaceutical industry, and helping Chinese pharmaceutical companies to go international. market.
Innovation to improve access to good medicine
"Orphan drugs" are difficult to buy, anticancer drugs are too expensive, and foreign anticancer drugs are "hard to find a drug"... As people's health needs continue to improve, the voice of the masses on medical innovation and the reform of the drug review and approval system is growing. .
The various reform measures stipulated in the "Opinions" are undoubtedly a "great package" for the people's health. “Guiding the development and production of generic drugs to improve the accessibility of public drugs†“Strengthening the life cycle management of pharmaceutical medical devices†“Incorporating new drugs into the scope of payment for basic medical insurance and supporting the research and development of new drugsâ€... Yang Junbin believes that the reform measures proposed in the “Opinions†Pointing to the health needs of the masses and adjusting the R&D ideas of the enterprise with clinical orientation can break the long-term embarrassing situation of serious homogenization of pharmaceutical production, and not only encourage enterprises to develop more effective new drugs that the masses need, but also encourage enterprises to produce A generic drug with the same quality and efficacy as the original drug.
Wang Jinsong, CEO of Platinum Pharmaceuticals, praised that the Opinions are guided by the health needs of the people, and firmly grasp the fundamental goal of meeting the needs of the public for drug use, and firmly grasp the safety, effectiveness and quality controllability of drugs. The key is to have a significant positive impact on promoting China's pharmaceutical innovation, optimizing the industrial structure, improving the quality of medicines, improving the accessibility and affordability of the people's medications, so as to achieve timely and affordable use of new medicines.
"I hope to see the implementation guidelines or guiding principles of the "Opinions" as soon as possible." Xu Yanjun said that with the world's largest health market, supported by the party and national policies, China's vision of moving from a pharmaceutical power to a pharmaceutical powerhouse can be expected. The safety and health of medications will also be more secure.
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