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
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Data shows that the operating income of China's pharmaceutical manufacturing industry in 2022 reached 4.2 trillion yuan. It can be said that China has now entered the ranks of big pharmaceutical countries. What innovative practices have the NMPA adopted in serving the high-quality development of the pharmaceutical industry? Thank you.
Jiao Hong:
Thank you for your question. The high-quality development of the pharmaceutical industry is a common concern to us all. I would like to invite Mr. Zhao Junning to introduce the specific situation.
Zhao Junning:
Thank you for your question. The pharmaceutical field is a highly innovative field. The report to the 20th CPC National Congress pointed out that high-quality development is the top priority of building a modern socialist country in all respects and an essential requirement of Chinese modernization. The next five years will be an important stage for new breakthroughs in China's high-quality economic development. In terms of the pharmaceutical field, China is at an important historical stage of leapfrogging from a big pharmaceutical country to a pharmaceutical powerhouse, from being dominated by generic drugs to being led by innovative ones, and from high-speed growth to high-quality development. To better achieve high-quality development of the pharmaceutical sector, in recent years, the NMPA has been committed to improving drug supervision capabilities and building a scientific, efficient and authoritative drug supervision system in the new era. The main work has been in the following aspects:
First, we have innovated the legal and technical systems. We have accelerated the improvement of the laws and regulations system and technical standards system that support the high-quality development of the industry, formulated high-quality development plans, promoted the implementation of the innovation-driven development strategy in the pharmaceutical field, prioritized the review and approval of innovative drugs and medical devices, and supported the clinical promotion and application of innovative products, in a bid to guide the high-quality development of the pharmaceutical sector.
Second, we have expedited the scientific research of supervision. Since 2019, the NMPA has closely followed the frontiers of international regulatory development, and designated more than 110 NMPA key laboratories in two batches, including well-known domestic universities and scientific research institutions, in accordance with the principles of urgent needs, classified implementation, regional coordination and rational layout. Relying on well-known domestic universities and scientific research institutions in this regard, 14 regulatory science research bases have been established. Aiming to address the key, hot and difficult issues of drug supervision, in conjunction with the NMPA regulatory science research bases, key laboratories and well-known domestic universities and scientific research institutions, we have launched and implemented two groups of 19 key regulatory science projects. At present, a "three-in-one" regulatory science innovation support system has been formed, including regulatory science bases, NMPA key laboratories, and provincial and municipal drug inspection and testing institutions. In the past four years, a total of 187 drug review technical guidelines, inspection and evaluation standards, and inspection and testing methods have been launched through regulatory scientific research, providing strong support for the scientific supervision of drugs.
Third, we have actively participated in international cooperation and coordination. The NMPA has joined organizations such as the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party (GHWP) and completed an application for "pre-accession" to the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to create a good international environment for the high-quality development of the industry.
Next, the NMPA will take high-quality development as the key, and concentrate on the international frontier, scientific and technological innovation and the urgent needs of drug regulation by formulating and implementing a plan on comprehensively strengthening the construction of a drug regulatory scientific research system during the 14th five-year period. We will prioritize the construction of comprehensive key laboratories for drug regulatory science to comprehensively strengthen the national strategic scientific and technological strength in the field of drug regulation. We will launch the research and demonstration of the third group of key regulatory science projects, and strengthen cooperation with the industry. We will continue to develop new tools, new standards and new methods for drug supervision, promote the in-depth development of regulatory scientific research, strengthen technical support for drug supervision, continuously deepen international cooperation, promote the modernization of the drug regulatory system and regulatory capabilities, and fully promote the high-quality development of the pharmaceutical industry.
Thank you.
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