Draft Technical Guidance Principles for Pharmaceutical Research on Traditional Chinese Medicine Compound Preparations Managed in Accordance with the Catalog of Time-Honored Classic Formulas: Solicitation of Comments
Release Date:
2021-05-12
Recently, the Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as the CDE) released the “Technical Guidance Principles for Pharmaceutical Research on Traditional Chinese Medicine Compound Preparations Managed in Accordance with the Catalog of Time-Honored Classic Prescriptions (Draft for Comments)” (hereinafter referred to as the “Draft for Comments”), with the deadline for submitting comments set for May 25.
Traditional Chinese medicine compound preparations managed in accordance with the Catalogue of Time-Honored Classic Prescriptions are classified as Category 3.1 under the TCM registration system (hereinafter referred to as TCM Category 3.1). According to the “Classification of TCM Registration and Requirements for Submission Materials” issued by the National Medical Products Administration in September 2020, TCM Category 3.1 requires the submission of process documentation based on research conducted in accordance with the key information on time-honored classic prescriptions and historical textual records published by the state, and such R&D activities must be carried out on the basis of the nationally published catalogue of time-honored classic prescriptions and their associated key information. In November 2020, the State Administration of Traditional Chinese Medicine and the National Medical Products Administration jointly issued the “Principles for Verifying the Key Information of Time-Honored Classic Prescriptions” and the “Table of Key Information for Time-Honored Classic Prescriptions (Seven Formulas).” Against this backdrop, in order to preserve the essence of traditional knowledge and promote the R&D and registration of TCM Category 3.1 products, the Center for Drug Evaluation has organized the drafting of a Consultation Draft.
The Draft for Soliciting Opinions sets forth four fundamental principles for pharmaceutical research on Class 3.1 traditional Chinese medicines: “clarify key information,” “emphasize research on reference standards,” “strengthen quality control at the source to ensure formulation quality,” and “focus on correlation studies and establish a comprehensive, end-to-end quality control system.” The formulation composition, botanical origin of the medicinal materials, parts used, processing specifications, converted dosages, methods of administration and dosage, as well as the functions and indications of classical ancient formulas shall be clearly defined as the basis for the research and development of Class 3.1 traditional Chinese medicines, and must be consistent with the key information on classical ancient formulas published by the state. In accordance with the state-issued key information on classical ancient formulas and historical textual records, reference samples shall be studied and prepared, with the goal of achieving basic consistency in quality between the finished preparation and the reference sample, and the production process for commercial-scale preparations shall be determined through such studies. During the R&D and manufacturing of Class 3.1 traditional Chinese medicines, quality control over both raw medicinal materials and processed herbal slices should be strengthened across multiple aspects, including botanical origin, place of origin, cultivation and breeding practices, growth duration, harvesting and processing, preparation of crude herbal slices, and packaging and storage, so as to ensure the quality of the final preparation at the source. Based on the key information on classical ancient formulas published by the state, the quality of raw materials and processed herbal slices shall be investigated, reference samples shall be prepared, and correlation studies shall be conducted among raw materials, processed herbal slices, intermediates, and finished preparations to identify critical quality attributes and critical process parameters. On this basis, a comprehensive quality-control system tailored to the characteristics of traditional Chinese medicine shall be established and refined to ensure the quality, uniformity, and stability of the medicinal product.
The Draft for Soliciting Comments sets forth requirements pertaining to medicinal materials, processed herbal slices, reference standards, pharmaceutical formulation production, formulation quality research and quality standards, correlation studies, and stability. For example, with respect to crude medicinal materials, the sourcing should be limited to authentic or principal production areas; in general, quality studies and analyses should be conducted on no fewer than 15 batches of materials from at least three different origins to establish information on the material’s place of origin, cultivation duration, harvest period, on-site processing, and quality requirements. Herbal decoction pieces should be prepared using the materials identified through these studies. Based on the results of material quality analysis and correlation studies, comprehensive quality standards for the crude materials should be developed. Regarding stability, the shelf life should be determined on the basis of long-term stability study data. As a general rule, applicants are required to submit data from a 6-month accelerated stability study and an 18-month long-term stability study at the time of application. Following marketing authorization, stability studies should continue to be conducted.
Article by Luo Nan, China Pharmaceutical News
Source: China Pharmaceutical News
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