With the economic and social development of China, the public's expectation for the safety and effectiveness of drugs is constantly improving. The people are looking forward to using more "good medicine" while entering the market. In recent years, China has introduced a number of policies to encourage drug innovation, and drug development and innovation have therefore entered the fast lane
Drug safety concerns people's physical health and life safety. At the first forum on drug policy and industrial innovation and development held recently, experts at the conference said that in recent years, a number of favorable policies have been introduced, and China has ushered in the golden age of medical innovation. In the next step, we must work hard to develop more new drugs and medicines to meet the needs of the public.
Policy environment is improving
With the continuous development of the innovation and research and development capabilities of China's pharmaceutical industry, the drawbacks of the drug registration management model bundled with marketing licenses and production licenses have become increasingly prominent. Yu Huan, director of the Department of Pharmaceutical Registration of the State Food and Drug Administration, said that although “bundling” supervision has played a role of strict supervision, due to the inherent deficiencies of the system, the regulatory authorities have wasted a lot of resources at low levels of repetition. On the review and approval of the application, it is impossible to form an effective drug life cycle supervision, which makes the pharmaceutical industry innovation weak.
In August 2015, the State Council issued the "Opinions on Reforming the Approval System for Drug Medical Device Evaluation and Approval", and proposed a pilot system for the implementation of the listing permit holder system, which opened the curtain for deepening the reform of China's drug regulatory system. Yu Huan said that the purpose of this round of reform is not only to solve the practical problems of backlog of drug review and approval, low quality of declared materials, and low quality of generic drugs, but also to establish a scientific, effective and complete drug regulatory system.
In June 2016, the General Office of the State Council issued the “Pilot Program for the License System for Drug Listings”, which greatly stimulated the enthusiasm of researchers for innovation. As of July 31 this year, 10 pilot provinces (cities) applicants submitted 450 applications for registration of pilot varieties, of which gefitinib, naproxate malate capsule, Jiuweihuangjiedu ointment and other varieties have become drugs for implementation. License holder variety.
Zhang Xiaoxiang, president of the China Medical News Information Association, said that the policy environment and institutional environment for drug innovation have changed a lot in recent years. However, in order to better meet the drug needs of the people, it is also necessary to solve the problem of insufficient innovation vitality. In October this year, the State Office of the State Council jointly issued the "Opinions on Deepening the Reform of the Examination and Approval System and Encouraging Innovation in Pharmaceutical Medical Devices." "The "Opinions" will be fully deployed from the aspects of review and approval, ensuring the quality of drugs and encouraging innovation. The situation of the public 'difficult to use new drugs and new medical devices will be expected to change." Zhang Xiaoxiang said.
Innovative results accelerate conversion
The promulgation of the "Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices" not only blew the horn of China's pharmaceutical innovation, but also ushered in the golden age of pharmaceutical innovation." Southern Medicine Economic Research of the State Food and Drug Administration Tao Jianhong, deputy director of the institute, told the "Economic Daily" reporter that since 2016, the number of new drug registrations in China has accounted for 55% of the total number of drug registration applications, basically eliminating the backlog of drug registration applications, and the drug registration application awaiting review has been 21,668 pieces in August 2015 fell to 3,000 in August 2017. The application for clinical trials of antibiotics and vaccines and the registration of Chinese medicines for ethnic medicines have also been reviewed on a time-limited basis.
In the interview, the reporter learned that at the China Medical City in Taizhou, Jiangsu, more than 800 well-known domestic and foreign pharmaceutical companies such as Nestle, AstraZeneca, Takeda Pharmaceutical, Shiyao Pharmaceutical and Haiwang Pharmaceutical have been gathered. More than 1,600 international The first-class, domestically leading pharmaceutical innovations have been successfully declared. According to Lu Chunyun, secretary of the Party Working Committee of Taizhou Pharmaceutical High-tech Zone in Jiangsu Province, there are currently 72 new types of new drugs being researched and declared in the park, and 20 new drugs have been approved for clinical approval. Among them, Fudan Zhangjiang's core product, Heimbofen, is the world's first drug for port wine stains. It is one of the two new drugs of class 1.1 that received production approvals in 2016, and a new class of medicine from Jiangsu Jindike Biotech Co., Ltd. The virus lysing vaccine (tetravalent) is one of only two declared vaccine varieties in the country.
Lu Chunyun said that in the next step, China Medical City will shift from enterprise concentration to resource agglomeration, continuously improve its technological innovation capability, continue to accelerate the transformation of innovation achievements, and build China Medical City into a national first-class innovative feature park and world-class biomedical research and development. Production base.
The regulatory system continues to improve
Drug safety is inseparable from strict supervision. On October 23, the State Food and Drug Administration issued the "Amendment of the Drug Administration Law of the People's Republic of China (Draft for Soliciting Opinions)". The biggest highlight of this revision is that from the past product and enterprise bundling, the management concept with the production enterprise as the core has been transformed into the separation of products and enterprises, and the system of listing license holders has been adopted to focus on the management ideas of product supervision.
The report of the 19th National Congress of the Communist Party of China pointed out that the main contradiction in our society has been transformed into "the contradiction between the people's growing needs for a better life and the development of inadequate imbalances." "Among the 29 typical new drugs listed in the past 10 years, China has an average night market of 7 years than the United States." Liu Pei, inspector of the Legal Department of the State Food and Drug Administration, said. In the pharmaceutical industry, there is also a contradiction between the promotion of industrial development and the inadequate imbalance of public drug demand. The fundamental purpose of amending the Drug Administration Law is to ensure the public's demand for drugs and to ensure that drugs are safe and accessible.
With the continuous development of modern medicine, the definition and classification of new drugs have also been given the characteristics of the times. Liu Pei said that the revision of the Drug Administration Law will further study the definitions of modern and traditional medicines, new and generic drugs, prescription drugs and non-prescription drugs. The concept of counterfeit drugs will be more precise in the future, and severely crack down on intentional and serious negligence. Effectively distinguishes from violations of GMP (Good Manufacturing Practices).
In addition, the Drug Administration Law will introduce a patent link system in the future to link the drug approval process with the patent infringement approval process. The specific measures will be jointly discussed and formulated by the drug regulatory authority in conjunction with the patent administration department and submitted to the National People's Congress for authorization.