“Registration Classification and Submission Requirements for Traditional Chinese Medicines” Released!
Release Date:
2020-10-05
Notice of the National Medical Products Administration on the Publication of “Classification of Traditional Chinese Medicine Registration and Requirements for Submission of Regulatory Documentation” (No. 68 of 2020)
In order to implement the Drug Administration Law and the Traditional Chinese Medicine Law and to support the enforcement of the Measures for the Registration of Drugs (Order No. 27 of the State Administration for Market Regulation), the National Medical Products Administration has formulated the Classification of Traditional Chinese Medicine Registration and the Requirements for Submission of Registration Dossiers, which are hereby promulgated as follows.
II. To strengthen the collation and excavation of the essence of classical medical texts, reform and improve the review and approval mechanism for traditional Chinese medicines, and promote the research and development of new TCM drugs and the growth of the TCM industry, the third category of TCM registration—namely, compound preparations derived from ancient classic prescriptions—is further subdivided into “3.1 Compound Preparations Derived from Ancient Classic Prescriptions Managed in Accordance with the Catalog of Ancient Classic Prescriptions (hereinafter referred to as Category 3.1)” and “3.2 Other Compound Preparations Derived from Ancient Classic Prescriptions (hereinafter referred to as Category 3.2).” Category 3.2 encompasses both compound preparations derived from ancient classic prescriptions that are not managed in accordance with the Catalog of Ancient Classic Prescriptions and compound preparations based on modifications and adaptations of such prescriptions.
III. For both categories of traditional classic prescription Chinese medicinal compound preparations, preparation shall be conducted using conventional manufacturing processes, administration shall follow traditional routes, and the functions and indications shall be described in terms of TCM terminology. No restrictions shall be imposed on the scope of application. The drug approval number shall adopt a dedicated format: “National Drug Approval Number C” followed by a four-digit year code and a four-digit sequential number.
4. For the development of Category 3.1 products, pharmaceutical and non-clinical safety studies shall be conducted; for Category 3.2 products, in addition to pharmaceutical and non-clinical safety studies, a systematic summary of human use experience with the traditional Chinese medicine shall also be prepared, and the clinical value of the drug shall be evaluated.
Upon completion of the aforementioned studies, the registration applicant (hereinafter referred to as the “Applicant”) shall submit a single, direct application for marketing authorization of the traditional Chinese medicine compound preparation derived from ancient classic prescriptions. With respect to Category 3.1, our bureau will no longer review and issue a unified standard for the “Substance Reference Standards for Classic Prescriptions.”
The Center for Drug Evaluation of the National Medical Products Administration conducts technical reviews by experts in accordance with the drug marketing authorization review procedures stipulated in the Measures for the Administration of Drug Registration.
V. With regard to the classification of traditional Chinese medicine registration, the relevant regulations have been in effect since July 1, 2020. For applications for the registration of traditional Chinese medicines that have already been accepted and require adjustment of the registration classification, the applicant may withdraw the application and resubmit it in accordance with the new registration classification and the corresponding submission requirements; no additional fees will be charged for such resubmission.
VI. With regard to the registration application dossiers for traditional Chinese medicines, applicants may, prior to December 31, 2020, submit their applications in accordance with the new requirements or, alternatively, initially submit them in accordance with the original requirements. Effective January 1, 2021, all applications must be submitted in accordance with the new requirements.
VII. In the event of any inconsistency between previous relevant provisions and the requirements of this Notice, the provisions of this Notice shall prevail.
Hereby notified.
Attachment: Classification of Traditional Chinese Medicine Registration and Requirements for Submission of Application Materials
Recommended News
Contact Information
No. 112, Section 4, Heping Street, Longcheng District, Chaoyang City, Liaoning Province
WeChat Official Account
Online Pharmacy
JD.com store