SCIO briefing on strengthening drug regulation to ensure drug safety for the public
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E-mail China.org.cn, July 28, 2023
Xing Huina:
We will have one last question.
China Daily:
In recent years, a slew of laws and regulations for medicine supervision and administration have been issued. Could you brief us on the developments in the formulation, revision, and standard system construction of these laws and regulations? What important laws and regulations will be pushed forward this year? Thank you.
Jiao Hong:
Thanks for your questions. We all know that good laws are a prerequisite for good governance and that standards are significant and fundamental support for industrial development. The NMPA has attached great importance to this respect. I will invite Mr. Xu to answer this question.
Xu Jinghe:
Thanks for your question. Drug safety affects the health and lives of the general public. General Secretary Xi Jinping once proposed the "four most stringent requirements" (the most stringent standards, the most stringent supervision, the most severe penalties, and the most serious accountability) for drug safety, with the first, the most stringent standards, directing the improvement of China's legal and standard system for medicine regulation. Over the past five years and more, the NMPA has firmly implemented the major decisions and deployments of the CPC Central Committee and the State Council, stuck to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, systematically reconstructed the system of medicine supervision and administration laws and regulations, constantly improved the standard system, and upgraded and modernized the system of China's drug supervision and administration laws and regulations with the greatest efforts.
First, we have comprehensively formulated and revised the drug supervision and administration laws and regulations. China's Vaccine Administration Law, adopted in June 2019, is the world's first comprehensive vaccine administration law. The law focuses on the strategic importance and public interest of vaccines, encourages vaccine R&D and innovation, and fully ensures the quality and safety of vaccines. As Mr. Huang just said, the vaccine R&D, production, operation, and application are all going forward under the system of laws and regulations. The newly revised Drug Administration Law, adopted in August 2019, has consolidated and deepened the achievements of drug assessment and approval system reform. It stipulates comprehensively implementing the marketing authorization holder system and fully strengthening the quality control of drugs throughout their life cycle. With the release of the Regulations on the Supervision and Administration of Cosmetics and the revision of the Regulations for the Supervision and Administration of Medical Devices, the "four beams and eight pillars" of the system of medicine supervision and administration laws and regulations have been established.
Second, we have systematically improved the supporting regulations, normative documents, and technical guidelines. China has issued 13 regulations related to drugs, medical devices, and cosmetics, with nearly 40 supporting regulations covering all links in the whole process, including developing, producing, selling and using, drug, medical equipment, and cosmetics. More than 50 important normative documents have been introduced, including an early resolution mechanism for drug patent disputes, post-marketing changes in the management of drugs, clinical trial management for medical devices, and cosmetics labeling management, which has clarified the primary responsibilities of enterprises to ensure quality and safety throughout the entire life cycle in a detailed manner. Technical guidelines for the conditional market approval of drugs, clinical evaluation of medical devices, and the safety assessment of cosmetics, among others, have been issued. At present, there are 459 drug technical guidelines and 559 medical device technical guidelines, which have effectively promoted product R&D and marketing.
Third, we have constantly improved the standard systems. The 2020 Edition of the Pharmacopoeia of China came into force in 2020, forming the national drug standard system centering on the pharmacopoeia and significantly improving drug quality controls and safety. The medical device standard system has been improved and optimized, and the number of effective medical device standards has amounted to 1,937, with the degree of consistency with international standards reaching more than 90%. The standard system framework for cosmetics has been built, and the revision of cosmetics safety technical specifications has been initiated. The standard systems for drugs, medical devices, and cosmetics have continuously become more broad, systematic, and internationally coordinated.
2023 is the first year when we fully implement the guiding principles of the 20th CPC National Congress. The NMPA will continue to strengthen the system of drug supervision and administration laws and regulations, accelerate the revision of the Regulations for Implementation of the Drug Administration Law and the Regulations on the Protection of Traditional Chinese Medicines, promote the release of Provisions for the Supervision and Administration of the Quality of Drug Operation and Application, initiate the revision of Provisions for the Administration of Radioactive Pharmaceuticals, Provisions for Classified Administration of Prescription and Non-prescription Drugs, as well as other laws and regulations, and launch the compilation of the 2025 Edition of the Pharmacopoeia of China. We will enhance systematic support, advance integration and optimization, and develop a coordinated, efficient, systematic, and sound system of drug supervision and administration laws, regulations, and standards so as to better serve and guarantee the high-quality development of the pharmaceutical industry as well as better serve, protect, and promote public health. Thank you.
Xing Huina:
Today's press conference is hereby concluded. Thanks to the four speakers and friends from the media. Goodbye!
Translated and edited by Wang Yiming, Wang Qian, Liu Jianing, Zhou Jing, Qin Qi, Liu Sitong, Ma Yujia, Yan Xiaoqing, Liu Caiyi, Huang Shan, Lin Liyao, Yang Xi, Yan Bin, Yuan Fang, Xu Xiaoxuan, Wang Yanfang, Li Huiru, David Ball, and Jay Birbeck. In case of any discrepancy between the English and Chinese texts, the Chinese version is deemed to prevail.
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