Drug R&D entered the "golden age"
In 2020, the reform of China's drug evaluation and approval system will enter the fifth year.
This year, the dividend of drug review reform was fully released: the Drug Administration Law and the Vaccine Administration Law were officially implemented, a series of detailed and grounded supporting rules and regulations such as the Drug Registration Administration Measures were successively introduced, and the drug review mechanism and review technology system were constantly improved, further stimulating the vitality of pharmaceutical innovation, promoting China's pharmaceutical research and development from imitation to innovation, and from the local to the global, Constantly meet the new needs of the public for life and health.
Registration of new regulations to guide the industry to gather in innovation
The reform of drug evaluation and approval system since 2015 has been promoted to a higher level this year. On July 1, the newly revised Measures for the Administration of Drug Registration (hereinafter referred to as the Measures) was officially implemented. The Measures implemented the Drug Administration Law and the framework blueprint for the reform of the drug review and approval system, introduced new ideas and system design, further optimized the process, improved measures, and encouraged drug research and innovation. For example, the Measures specially added a chapter on accelerating the registration of drugs in the market, and established four accelerated channels, namely breakthrough therapeutic drugs, conditional approval, priority review and approval, and special approval, to support clinical value oriented drug innovation. In addition, the risk-based review, inspection and testing model implemented in the Measures, which changed the original review, inspection and testing from "series" to "parallel", and the implicit licensing system and communication system of clinical trials, have created conditions for accelerating the listing of products, and have been widely praised by the industry.
Before and after the implementation of the Measures, a series of supporting rules and regulations were also issued. On June 30, the State Food and Drug Administration issued the Registration Classification and Application Materials of Biological Products and the Requirements for Registration Classification and Application Materials of Chemical Drugs. It is clear in the documents that new drugs are divided into innovative drugs and improved new drugs, which are not listed at home and abroad and have clinical value. However, in the "Classification of Traditional Chinese Medicine Registration and Application Data Requirements" issued on September 28, it was clarified that the registration of traditional Chinese medicine was classified according to traditional Chinese medicine innovation drugs, traditional Chinese medicine improved new drugs, ancient classic famous traditional Chinese medicine compound preparations, the same name and the same prescription drugs. The first three categories were all new traditional Chinese medicine drugs. Song Ruilin, president of the China Association for the Promotion of Pharmaceutical Innovation, believes that the new registration classification method has a very positive significance in promoting China's pharmaceutical innovation and the development of the pharmaceutical industry: it clarifies the classification of innovative drugs and improved new drugs for chemical and biological products, which is conducive to guiding scientific research institutions and research institutes to clarify the direction of research and development, and establishing the research and development goal of filling clinical gaps and achieving effective substitution; The expansion of traditional Chinese medicine from the original scope of traditional classical prescriptions and traditional Chinese medicine theories in the past has built an important channel for the convergence of traditional Chinese medicine, a treasure house of traditional Chinese medicine, with modern medicine, and opened up a broader prospect for the conservation and innovation of traditional Chinese medicine.
The review resources are inclined to accelerate the listing of innovative drugs
On July 8, the State Food and Drug Administration issued three important documents, including the Work Procedures for the Review of Breakthrough Therapeutic Drugs (Trial), the Work Procedures for the Review and Approval of Conditional Drug Approval Applications (Trial), and the Work Procedures for the Priority Review and Approval of Drug Marketing Licenses (Trial), together with four "high-speed channels" for the listing of new drugs. The document clarifies the scope of application and policy support measures of the above three working procedures respectively - for example, breakthrough therapeutic drugs can be submitted in a rolling manner during clinical trials, and priority can be given to review if communication and guidance are obtained from the Drug Examination Center; For drugs with priority for review, materials can be submitted on a rolling basis at the marketing application stage, so as to shorten the review time limit and give priority to verification and inspection.
Within one week after the release of the document, four enterprises submitted applications for incorporating breakthrough therapeutic drugs into their innovative products. It is self-evident that enterprises pay attention to "high-speed channel".
At the same time as the new regulations were implemented, the Drug Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Drug Evaluation Center) further prioritized the evaluation work, adjusted the scope of priority evaluation according to law, and included more shortage drugs and innovative drugs with significant clinical value and urgent clinical needs in the priority evaluation procedure. At the just concluded 2020 Smart Regulatory Innovation Conference, Kong Fanpu, director of the Center, said that 212 cases had been included in the priority review and approval procedures and 241 cases had been concluded by the end of November this year. Among them, 35% are new drugs with obvious clinical value, and 20% are simultaneously declared products. The completion rate of priority review and conclusion tasks has increased month by month according to the time limit, reaching 97.22% by November, effectively promoting innovative drugs and drugs in clinical shortage and the morning market.
The review speed of clinically urgently needed new drugs from abroad was also accelerated at the same time. On October 29, the Drug Review Center announced the third batch of clinically urgently needed new drugs from abroad, and seven drugs involving blood system diseases, genetic metabolic diseases, nervous system and other diseases were selected. Up to now, in the three batches of the list, 36 enterprises have applied for registration of 45 varieties, 39 varieties have been approved for listing or completed the review, and 100% of the review tasks have been completed within the time limit.
International cooperation is close, and the trend of synchronous research and development of new drugs is obvious
At present, China's pharmaceutical innovation ability has become the second echelon in the world. On October 17, the newly revised Patent Law was promulgated. An early resolution mechanism for drug patent disputes was added to the articles of the law, and a compensation system for the patent term of new drugs was proposed for the first time at the legislative level, which gave innovative pharmaceutical enterprises a "reassuring pill", greatly improved the attractiveness of China as the first place for new drugs to be listed, and promoted the early listing of new drugs worldwide in China.
According to statistics, by the end of November this year, nine Class 1 innovative drugs, including clomivir hydrochloride and phencyquine ammonium bromide nasal spray, had been approved for marketing, seven of which were declared by domestic enterprises. In addition, Zebutinib capsules from Baekje Shenzhou and Sinimod tablets from Novartis were simultaneously declared products.
In fact, at the same time as the third batch of overseas new drugs in urgent clinical need were announced, In its announcement, the Drug Approval Center has clearly pointed out that "the historical legacy of slow marketing of new drugs in China, which are urgently needed in clinical practice, has been basically solved. With the deepening of the reform of the review and approval system and the transformation and implementation of the ICH guiding principles, China has gradually established a regulatory system for simultaneous R&D and declaration of overseas new drugs in China, and encourages the simultaneous R&D and declaration of overseas new drugs in China."
With the rapid development of innovation and R&D in China, the R&D model of multinational pharmaceutical enterprises in China is also being updated. It is an obvious trend to further strengthen innovation cooperation. At the recently concluded Third China International Import Expo, An Sijia, Chairman of the Executive Committee of RDPAC (Pharmaceutical Research and Development Industry Committee of China Association of Enterprises with Foreign Investment) and President of Xi'an Janssen Pharmaceutical Co., Ltd., said that many RDPAC member enterprises had conducted a lot of cooperation with local pharmaceutical enterprises in scientific research, medicine, commerce and other aspects, including both large-scale pharmaceutical enterprises and start-up pharmaceutical enterprises, "If we win together in a fair, transparent and perfect pharmaceutical ecosystem and business environment, we believe that this will be very beneficial to the development of pharmaceutical enterprises and China's pharmaceutical industry."
Many foreign enterprises such as Novo Nordisk, Roche and Takeda are bringing China into the global R&D system. Zhou Fude, global president and CEO of Novo Nordisk, said that Novo Nordisk will bring 10 innovative drugs in multiple disease fields in the next seven or eight years
In addition, the cooperation between foreign pharmaceutical enterprises and Hainan Boao Lecheng International Medical Tourism Pilot Zone in the introduction of innovative drugs is one of the best examples of international cooperation to help healthy China. The application of real world clinical data in Lecheng pilot area has received common policy support from the State Food and Drug Administration, the Customs, the Health Commission, the National Development and Reform Commission and the Ministry of Finance, which has opened a special "green channel" to meet the treatment needs of patients in China.