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E-mail China.org.cn, October 16, 2024
Jinan Daily APP:
As we know, traditional Chinese medicine (TCM) is an essential component of our country's conventional pharmacology and a treasure of the Chinese nation. What efforts have medical regulatory departments made to promote the preservation and innovative development of TCM? Thank you.
Li Li:
Thank you for your question. TCM is the material foundation for the inheritance and innovative development of Chinese medicine. The NMPA is continuously improving its regulatory system to align with the unique characteristics of TCM. I will invite Mr. Zhao Junning to answer this question.
Zhao Junning:
I'll answer this question. The NMPA has diligently implemented the policy decisions and plans of the CPC Central Committee and the State Council. We've upheld fundamental principles while breaking new ground, taking multiple steps to promote the preservation and innovative development of TCM.
First, we're improving regulatory frameworks to guide the development of TCM. We are advancing revisions to the Regulations for Implementation of the Drug Administration Law and the Regulations on the Protection of Traditional Chinese Medicines. We have successively issued the Special Provisions for Traditional Chinese Medicines Registration, and the Special Provisions on the Administration of Traditional Chinese Medicine Standards, and are currently studying and formulating special provisions for the supervision and administration of TCM production. Previously, we have published Good Agricultural Practice (GAP) for Chinese Crude Drugs. All of this has actively strengthened our regulatory framework. We have also issued measures for further strengthening the scientific supervision of TCM to promote its inheritance and innovative development, introducing 35 measures in total. These measures follow TCM's unique regulatory characteristics, comprehensively promoting the preservation and innovative development of TCM across the entire chain.
Second, we're reforming the review and approval process to drive the development of TCM. Fully respecting the laws governing the development of Chinese medicine, we have innovatively established an evidence system for TCM registration and review that integrates TCM theories, human use experience, and clinical trials. This "three-in-one" evidence approach allows us to clearly articulate the logic behind TCM's safety, efficacy and quality control, supporting the market launch of new TCM drugs. In recent years, enthusiasm for the research and development of new TCM drugs has surged. The number of clinical trials, market authorization applications, and approvals for new TCM drugs have increased in tandem, all reaching double digits in each of the past two years. In 2023, 10 new TCM drugs were approved for market launch. This year, eight new drugs were launched, offering new options to meet clinical needs.
Third, we're establishing a regulatory system to safeguard the development of TCM. We adhere to a problem-oriented and risk management approach, continuously conducting annual special inspections of TCM production, for-cause inspections, random inspections, exploratory research, and quality monitoring of Chinese medicinal materials. We're deepening efforts to consolidate and improve drug safety, strengthening oversight of online drug sales, and optimizing the distribution and management of Chinese medicinal materials. We're exploring ways to standardize the processing of Chinese medicinal materials at their source and guide the orderly development of Chinese medicinal materials production, improving quality from the outset. The overall passing rate for TCM decoction pieces has risen from 88% in 2018 to around 97% currently. The overall pass rate for TCM drugs has remained stable at over 99% for a long time, effectively ensuring that TCM plays a vital role in clinical practice. The demonstration and promotion of GAP for Chinese crude drugs are showing initial results, effectively stimulating the internal drive of TCM production enterprises.
That's all for this question. Thank you!
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