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
Southern Metropolis Daily:
What has the NMPA done in recent years to promote TCM's inheritance and innovative development, and what has been the effect? Are there any new ideas and measures this year? Thank you.
Jiao Hong:
Thanks for your questions. Promoting TCM's inheritance and innovative development is part of the NMPA's focus. Next, Mr. Zhao will provide more information.
Zhao Junning:
Thank you for your interest in our efforts to promote the inheritance and innovative development of TCM. The advancement and innovative development of TCM is a major decision made by the CPC Central Committee. In recent years, the NMPA has continued to deepen the reform of the review and approval system of TCM, while also consistently enhancing the supervision system for the entire chain and whole life cycle of TCM. It's fair to say that the supervision of TCM and the development of the TCM industry have achieved remarkable results.
First, we have accelerated the introduction of new TCM products. We fully acknowledge the unique characteristics of TCM. In February this year, we released the "Regulations on the Registration Administration of TCM," which adjusted the classification of TCM registration. This led to the creation of a new TCM registration review system that combines TCM theory, human experience, and clinical trials. Thanks to the support of these policies, the number of clinical trials, commercialization applications, and approvals of new Chinese medicines have increased in unison. Since 2018, we have approved 31 new Chinese medicines for marketing, thus meeting the public's medicinal needs.
Second, we have enhanced the standard system of TCM. The NMPA has actively established the TCM standard system with national medicine standards as the backbone, supplemented by provincial standards. We released and implemented the 2020 edition of the Chinese Pharmacopoeia, which comprises 2,711 TCM standards, including 117 new ones and 452 revised ones. For the first time, we also introduced national processing standards for TCM decoction pieces, currently covering 61 varieties. As the pilot program of TCM formula granules has been successfully completed, we have expedited the creation of TCM formula granules standards. Currently, 248 national standards have been established, and nearly 7,000 provincial standards have been filed, involving approximately 700 varieties.
Third, we have improved the assurance of TCM quality and safety. We have insisted on a problem-oriented approach. In January, we issued measures for further strengthening the scientific supervision of TCM to promote its inheritance and innovative development, amounting to a total of 35 measures. In accordance with these measures, we have significantly enhanced supervision across the entire TCM industry chain, carried out special rectification of TCM decoction pieces, and conducted special inspections of production. We have amplified supervision of production and operations, and improved the monitoring of sampling and drug reactions. Additionally, we have also urged drug marketing authorization holders to conduct post-marketing evaluations, revised and improved safety information in instructions, and severely cracked down on violations of laws and regulations. As a result, the overall qualification rate of sampling quality for TCM decoction pieces has increased from 88% in 2018 to about 97% currently, and the overall qualification rate of proprietary Chinese medicine has consistently remained stable at over 98% for a long time.
Moving forward, we will continue to further promote the inheritance and innovative development of TCM, in alignment with the decision-making and strategic deployments of the CPC Central Committee and the State Council.
First, we need to enhance research on the TCM supervision system. We should establish an evaluation and approval system that aligns with the characteristics of TCM and fosters its innovative development. By adopting measures such as integrating research and review, and providing early-stage services for innovative TCM, we need to shift from merely accelerating the back end to speeding up the entire process, thereby further stimulating new vitality for the innovative development of TCM.
Second, we need to establish a standard management system for TCM. Building on the increasingly mature TCM standard system, we've researched and issued special regulations on the standard management of TCM, focusing on constructing a comprehensive TCM standard management system. Given the unique characteristics of TCM, we should also enhance the whole-life-cycle management of TCM standards
Third, we must fully implement the action plan to consolidate and maintain drug safety. We will persist in stringent supervision without laxity and crack down on violations of laws and regulations in the TCM sector. Our goal is to normalize market competition order through impartial oversight and foster a virtuous cycle of safety within TCM.
I would like to inform you that the second national conference on TCM scientific regulation will be held in Shanghai on July 18-19. The conference will concentrate on four main themes: TCM standards, registration, safety supervision, and scientific regulations. We warmly invite our media friends to continue their coverage and support for the conference.
Thank you.
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