“Technical Guidance Principles for Quality Research of New Traditional Chinese Medicines (Trial)” Issued and Implemented
Release Date:
2021-01-20
“The Technical Guidance Principles for Quality Research of New Traditional Chinese Medicines (Trial)” Issued and Implemented
Recently, the Center for Drug Evaluation of the National Medical Products Administration issued and put into effect the “Technical Guidance Principles for Quality Research on New Traditional Chinese Medicines (Trial)” (hereinafter referred to as the “Guiding Principles”). The Guiding Principles set forth fundamental principles such as adherence to the theoretical guidance of traditional Chinese medicine, equal emphasis on traditional quality-control methods and modern quality-research methodologies, and prioritizing the elucidation of the pharmacologically active substance basis as a key research focus. They also provide standardized guidance on aspects including quality control of crude herbs and processed herbal slices, intermediate-product studies, formulation-quality studies, and the interrelationships among quality research and stability studies.
The Guiding Principles state that, given the multi-component and complex nature of traditional Chinese medicines, quality research for new TCM drugs should be guided by clinical value and patient needs, adhere to the theoretical principles of TCM, integrate inheritance with innovation, and employ new technologies and methodologies from physics, chemistry, biology, and other disciplines to comprehensively investigate and analyze the quality characteristics of these products. At the same time, quality research should embody the principles of quality by design, comprehensive process-quality control, and risk management. This involves studying the transfer of both quantity and quality of medicinal substances and critical quality attributes across different stages—ranging from crude herbs and processed herbal slices to intermediates and finished dosage forms—and examining the mutual interactions between medicinal substances, excipients, and pharmaceutical packaging materials, thereby continuously enhancing the level of quality control for traditional Chinese medicines.
The Guiding Principles provide guidance from multiple perspectives. For instance, they emphasize the need to pay close attention to the impact of factors such as pesticide residues, heavy metals and harmful elements, and mycotoxins on the safety of medicinal materials throughout their cultivation, farming, production, processing, distribution, and storage. The Guiding Principles further state that, in light of the specific characteristics of the manufacturing processes, the quality of intermediates—including crude drug powders, concentrated solutions, and extracts—should be thoroughly investigated, particularly those intermediates that are directly used in pharmaceutical formulations. Moreover, depending on the specific characteristics of each drug product, its physicochemical properties, chemical composition, biological activity, and other factors relevant to safety and efficacy should be studied.
The Guiding Principles emphasize that, in light of the unique characteristics of new traditional Chinese medicines, quality studies on dosage forms should be conducted based on research into medicinal materials/processed herbal slices, intermediates, and the manufacturing process of finished formulations, as well as stability studies, while integrating findings from studies on the pharmacological basis of the active constituents and on safety and efficacy. Particular attention should be paid to dosage form, formulation composition, manufacturing processes, and microbial control.
(Source: China Food and Drug Network; Reporter: Luo Nan)
Source: Website of the Center for Drug Evaluation, National Medical Products Administration
To further standardize and guide quality research on new traditional Chinese medicines and to promote the high-quality development of the TCM industry, the Center for Drug Evaluation, under the auspices of the National Medical Products Administration, has organized the formulation of the “Technical Guidance Principles for Quality Research on New Traditional Chinese Medicines (Trial)” (see attachment). In accordance with the requirements of the “Notice of the General Office of the NMPA on Issuing the Procedures for the Publication of Pharmaceutical Technical Guidance Principles” (NMPA General Office [2020] No. 9), and following review and approval by the National Medical Products Administration, these principles are hereby promulgated and shall enter into force as of the date of promulgation.
January 14, 2021
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