In the first half of the year, 24 innovative drugs and 28 innovative medical devices were approved for marketing in China | Drugs | Medical Devices
Beijing, July 5th - The State Council Information Office held a series of themed press conferences on July 5th, introducing China's strengthening of drug supervision and effectively ensuring the safety of medication for the people, and answering questions from reporters.
Since its establishment more than 5 years ago, the National Medical Products Administration has continuously deepened the reform of the drug and medical device evaluation and approval system, strengthened the quality supervision of drugs throughout their entire life cycle, maintained the overall stability of drug safety, and promoted China's transition from a pharmaceutical powerhouse to a pharmaceutical powerhouse. "By strengthening supervision, the overall qualification rate of national drug sampling has increased from 97.1% to 99.4%. In recent years, a total of 130 innovative drugs and 217 innovative medical devices have been approved. In the first half of this year alone, 24 innovative drugs and 28 innovative medical devices have been approved for marketing, effectively meeting the health needs of the people." said Jiao Hong, Director of the National Medical Products Administration.
Since the reform of the drug and medical device evaluation and approval system, the innovation level of China's pharmaceutical industry has significantly increased. What areas of innovation and research and development will be encouraged in the next step?
"Encouraging innovation is the core essence of the reform of the drug and medical device evaluation and approval system." Jiao Hong introduced that China will further optimize the relevant work procedures for conditional listing application evaluation and approval, while also continuing to optimize the approval work for clinically urgently needed drugs, medical devices, pediatric drugs, rare disease drugs, domestic substitute products, and "bottleneck" products. We will continue to promote the consistency evaluation of generic drug quality and efficacy, further encourage the research and development of radioactive drugs, and promote the pilot work of aging friendly drug instructions reform.
"From the perspective of the pharmaceutical industry, China is in an important historical stage of transitioning from a pharmaceutical powerhouse to a pharmaceutical powerhouse, from a focus on generic drugs to leading innovative drugs, and from high-speed growth to high-quality development." Zhao Junning, Deputy Director of the National Medical Products Administration, introduced that the Administration is committed to enhancing drug regulatory capabilities and building a "scientific, efficient, and authoritative" drug regulatory system in the new era. Since 2019, the National Medical Products Administration has recognized more than 110 key laboratories in two batches, relying on well-known domestic universities and research institutions to build 14 regulatory scientific research bases in different fields, and launched two batches of 19 regulatory scientific key projects. Over the past four years, through regulatory scientific research, a total of 187 technical guidelines for drug evaluation, inspection and evaluation standards, and inspection and testing methods have been developed, providing strong support for the scientific supervision of drugs.
In promoting the high-quality development of the medical device industry, Xu Jinghe, Deputy Director of the National Medical Products Administration, stated that "with the continuous implementation of multiple support policies, China's medical device industry has developed rapidly, with an average annual compound growth rate of 10.54% in the past five years, and has become the world's second largest market for medical devices. The degree of industrial agglomeration and international competitiveness are constantly improving.". Our country's innovative medical device products and clinically urgently needed products are queuing up separately and running fast. Currently, 217 innovative high-end medical device products such as domestic "brain pacemakers", carbon ion therapy systems, and proton therapy systems have been approved for market launch, achieving a breakthrough in the domestic production of high-end medical devices and solving the problem of some products heavily relying on imports. Most of these products have already served clinical diagnosis and treatment and achieved good results in use.
In recent years, new forms of online sales have developed rapidly. It is estimated that the online sales of drugs and medical devices in China reached 292.4 billion yuan last year, and it is expected to exceed 350 billion yuan this year. It is particularly necessary to strengthen the safety supervision of online sales of drugs, medical devices, and cosmetics.
Huang Guo, Deputy Director of the National Medical Products Administration, revealed that in order to comprehensively improve the convenience of online shopping and the quality and safety of drugs sold online, the National Medical Products Administration has taken three measures to strengthen supervision: first, to improve the rule of law. As of now, specialized supervision and management measures for online sales of drugs, medical devices, and cosmetics have been introduced, mainly clarifying the legal responsibilities of regulatory departments, operating enterprises, and third-party platforms, and requiring the strengthening of quality management throughout the entire online sales process. The second is to strengthen online governance. In response to the concealment and divergence of illegal and irregular behaviors in online sales, a "network management network" mechanism has been established, and the "fast governance" approach has been explored. Currently, full coverage network monitoring has been implemented for online sales enterprises and major third-party platforms. The third is to promote co governance. Strengthen collaboration among multiple departments, actively promote linkage with multiple departments such as Industry and Information Technology, Cyberspace, Health, and Market Regulation, and form a joint regulatory force; At the same time, pay attention to the role of industry associations, establish and improve industry norms, and guide industry self-discipline; We also encourage the active participation of news media, consumers, and others to build a collaborative management pattern for the whole society.
In terms of the prevention and control of COVID-19 epidemic in the new stage of service guarantee, Huang Guo said that he would continue to enrich the "anti epidemic toolbox". Previously, the State Food and Drug Administration has approved 15 COVID-19 therapeutic drugs or increased indications through special approval procedures, including 6 chemicals, 2 biological products, and the "three drugs and four directions" of traditional Chinese medicine. Five COVID-19 vaccines have been conditionally approved for marketing, of which 3 are listed in the emergency use list of the World Health Organization. In addition, emergency approval was also given to domestic ECMO and 151 COVID-19 detection reagents for marketing. The next step will continue to strengthen the quality supervision of epidemic related drugs and medical devices, ensuring the safety, effectiveness, and controllable quality of epidemic related products.
