Regulations on Simplified Registration and Approval for Compound Preparations of Classic Traditional Chinese Medicine Prescriptions(Draft for Comments)
First To implement Article 30 of the Traditional Chinese Medicine Law of the People's Republic of China and simplify the approval process for marketing authorization applications of traditional Chinese medicine compound preparations derived from ancient classic formulas listed in the national catalog (hereinafter referred to as "classic formula preparations"), these Regulations are hereby formulated.
Second The National Administration of Traditional Chinese Medicine, in conjunction with the China Food and Drug Administration, shall establish a directory of ancient classic formulas. This directory must include essential information for each formula, such as its source, ingredients and dosages, and preparation methods. The Drug Evaluation Center of the China Food and Drug Administration shall conduct evaluations in accordance with the requirements of this directory.
Third Classic formula preparations implementing simplified registration and approval shall meet the following conditions:
(I) Prescriptions do not contain incompatibilities or are marked as compliant with drug standards“Highly Toxic”“Highly Toxic”“Toxic”herbal ingredients proven toxic by modern toxicology;
(II) All Chinese herbal medicines in the prescription have national drug standards.
(3) The preparation method is consistent with ancient medical texts.
(4) The dosage form must be consistent with the records in ancient medical texts.
(5) The route of administration is consistent with ancient medical records, and the daily dosage of herbal slices is comparable to that recorded in ancient texts.
(6) Indications and functions shall be described using traditional Chinese medicine terminology consistent with ancient medical texts.
(7) Scope: Not for acute, critical, or infectious conditions; not intended for pregnant women, infants, or other special populations.
Article 4 The registration applicant for preparations of classic famous prescriptions (hereinafter referred to as the "applicant") shall be a pharmaceutical manufacturing enterprise legally established within China, capable of independently assuming responsibilities for drug quality and safety, and must comply with national industrial policies on investment.
Manufacturers must possess complete production capabilities for processing, extracting, concentrating, drying, and formulating Chinese herbal pieces, and comply with the requirements of Good Manufacturing Practice for pharmaceuticals.
Article 5 Manufacturing declaration for classic prescription preparations complying with the third requirement.Only pharmacological and non-clinical safety study data are required; efficacy study and clinical trial data are exempt. The applicant must ensure that the submitted data are accurate, complete, and traceable.
Article 6 Development of formulations for ancient classic prescriptions“Standard Decoction”Two stages: development and formulation. Applicants shall develop products in accordance with the prescriptions and preparation methods published in the Catalogue of Ancient Classic Prescriptions.“Standard Decoction”, and based on“Standard Decoction”Conduct research on preparations of classic formulas to demonstrate quality consistency between the two.
The aforementioned“Standard Decoction”Refers to Chinese medicinal substances prepared in accordance with the preparation methods of ancient classic formulas recorded in historical medical texts, except for the final shaping process; all other preparation methods must be substantially consistent with those recorded in the ancient texts.“Standard Decoction”shouldAs the benchmark for determining the medicinal substance of classic famous formula preparations。
Article 7 The applicant is listed by the National Medical Products Administration.Corresponding classic patent medicine preparations“Standard Decoction”For standard pre-production submissions, only the following may be provided:“Standard Decoction”relevant declaration documents, and at“Standard Decoction”Submit supplementary application materials for classic prescription preparations after the standard is published. Review.“Standard Decoction”The time spent does not count toward the review period. If additional research is required, the applicant may extend the deadline for submitting supplementary materials and must provide reasons to the Center for Drug Evaluation of the National Medical Products Administration.
Article 8 The Center for Drug Evaluation of the National Medical Products Administration received“Standard Decoction”Related materials5The information shall be published on its website within the day, with a publication period of six months. During the publication period, other applicants may continue to submit applications for the production of their independently developed [0] through the declaration and production procedure.“Standard Decoction”Relevant materials shall be made public simultaneously. Upon expiration of the publicity period, the Center for Drug Evaluation (CDE) of the National Medical Products Administration will convene experts to commence review of“Standard Decoction”Review.
Article 9 The Center for Drug Evaluation of the National Medical Products Administration shall, with respect to those that have undergone review,“Standard Decoction”Standardized information shall be made public (the publicity period is not included in the review timeline) and submitted to the National Medical Products Administration for publication after the publicity period.
Encourage applicants to participate“Standard Decoction”Standard research, drafting, and sharing of results upon publication“Standard Decoction”List the names of the drafting organizations in the standard.
Article 10 Before accepting an application for the production of classic formula preparations, the Center for Drug Evaluation (CDE) of the National Medical Products Administration shall arrange a meeting with the applicant to provide feedback and recommendations. The applicant shall revise and improve the submission materials based on the outcomes of this communication.
Article 11 Upon receipt of application materials for the production of classic prescription preparations from the Center for Drug Evaluation of the National Medical Products Administration, the Center shall organize experts to review the materials. If necessary, it may request the applicant to supplement the materials and provide reasons.
Article 12 If the review confirms compliance, the Drug Evaluation Center of the China Food and Drug Administration (CFDA) shall notify the applicant to apply for a production site inspection and inform the CFDA's Drug Inspection and Verification Center. Based on technical evaluation opinions, reports from sample production site inspections, and sample test results, the Drug Evaluation Center shall prepare a comprehensive opinion along with relevant materials and submit them to the CFDA. The CFDA shall then make an approval decision based on the comprehensive opinion.
If the review finds that the submission does not comply with regulations, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) will submit its review opinions and relevant materials to the NMPA. Based on the technical review findings, the NMPA shall issue a decision not to approve, provide the "Notification of Approval Decision," and state the reasons.
Article 13 Manufacturers of classic formula preparations shall bear full legal responsibility for the quality of raw medicinal herbs and excipients, preparation production, distribution and marketing, as well as adverse reaction reporting.。
Article 14 The manufacturing process for preparations based on classic patent formulas must align with the approved process and ensure consistent, stable compliance throughout production. Manufacturers shall cooperate fully with regulatory oversight by food and drug authorities, including inspections organized by these agencies, and may not refuse, evade, or obstruct such activities.
Article 15 The formulation of pharmaceutical standards for classic famous formulas should align with“Standard Decoction”Conduct comparative studies that comprehensively consider factors affecting quality across all stages—including herbal material sourcing, decoction piece processing, pharmaceutical manufacturing, and product usage—covering herbs, processed slices, and intermediates.“Standard Decoction”Conduct a comprehensive quality profile study of the dosage form, considering correlations to identify critical quality attributes (CQAs). Establish corresponding evaluation criteria and methods based on these CQAs to define scientifically sound and reasonable pharmaceutical standards. Strengthen specificity identification and multi-component, holistic quality control to fully reflect current best practices in pharmaceutical quality management.
Manufacturers shall establish strict internal control standards for pharmaceuticals, defining quality control measures, critical control points, and related quality requirements throughout the production process based on key quality attributes. The company's internal testing standards must not be lower than the drug registration standards.
Article 16 The names of preparations based on classic formulas should, in principle, match the original formula names found in ancient medical texts.
Article 17 The drug label for preparations of classic famous formulas must specify the exact source of the prescription and indications, confirm a long history of clinical use, document non-clinical safety evaluations, list the ingredients and dosages, and state that this product is a prescription-only medication for use in traditional Chinese medicine practice.
Article 18 After the market launch of preparations based on classic famous prescriptions, manufacturers shall conduct pharmacovigilance in accordance with the "Measures for the Reporting and Monitoring of Adverse Drug Reactions" and report any adverse drug reactions occurring during use to the drug regulatory authority. They shall also propose improvement measures and promptly revise the package insert.
Article 19 Pharmaceutical manufacturers shall submit an annual summary of drug production and sales, adverse reaction monitoring, post-marketing changes, and resource assessments, along with relevant explanations, to:Center for Drug Evaluation, National Medical Products Administration。
Article 20 The National Medical Products Administration issues alerts on excessive duplicate registration submissions to guide pharmaceutical manufacturers in orderly R&D and rational submission of classic formula preparations, preventing duplication and resource waste.
For approved products on the market but5If a classic prescription preparation is not produced or sold during the year, the food and drug regulatory authority shall not approve its re-registration.
Article 21 For the market approval of preparations based on classic prescriptions, in addition to simplified approval procedures as specified herein, regulatory requirements for submission acceptance, verification of development and original data, production site inspections, drug standard review, sampling and testing, post-market changes, and obligations of marketing authorization holders shall be implemented in accordance with applicable national regulations.
Article 22 This regulation shall take effect on the date of its publication.