State Drug Administration: Requirements for registration classification and declaration of Chinese medicine

On September 30th, the State Drug Administration issued a circular on the Requirements for the Classification and Declaration of Chinese Medicine Registration (No. 68 of 2020).
requirements, it is clear that the ancient classical prescription of Traditional Chinese medicine compound preparation two types of cases should be prepared using traditional technology, the use of traditional methods of medicine, the main function of traditional Chinese medicine terms.
does not limit the scope of application.
drug approval number in a special format: the national drug quasi-word C plus four-bit annual number and four-bit sequence number.
For Chinese medicine compound preparations managed according to the ancient classic prescription catalogue, the registered applicant, after completing the pharmaceutical and non-clinical safety research, directly put forward a one-time application for the listing license of the ancient classic prescription Chinese medicine compound preparation, the Drug Administration will no longer review and issue the "classic prescription material benchmark" unified standard.
description is as follows: 1, Chinese medicine registration classification: according to chinese medicine innovative medicine, Chinese medicine improved new drugs, ancient classic prescription Chinese medicine compound preparations, the same name, such as the classification.
New Chinese Medicine Classification: Innovative Chinese Medicine, Chinese Medicine Improved New Medicine, Ancient Classic Prescription Chinese Medicine Compound Preparation 2, Ancient Classic Prescription Chinese Medicine Compound Preparation a, Fine Classification: Class 3.1: Managed by Ancient Classic Prescription Directory Chinese medicine compound preparation 3.2 category: other Chinese medicine compound preparations from ancient classic prescriptions: ancient classic prescription Chinese medicine compound preparations not managed according to the ancient classic prescription catalogue;
b, the requirements of ancient classic prescription Chinese medicine compound preparation two types of situations should be prepared using traditional technology, the use of traditional methods of medicine, the main function of traditional Chinese medicine terms.
does not limit the scope of application.
drug approval number in a special format: the national drug quasi-word C plus four-bit annual number and four-bit sequence number.
c, the development of 3.1 categories of research, should be carried out pharmaceutical and non-clinical safety research, 3.2 types of research, in addition to pharmaceutical and non-clinical safety research, but also should be a systematic summary of the experience of Chinese medicine, and the clinical value of drugs to assess.
applicant (hereinafter referred to as the applicant) after completing the above-mentioned research, a one-time direct application for the listing of ancient classic prescription Chinese medicine compound preparations.
for category 3.1, our bureau will no longer review the release of "classic famous material benchmark" unified standards.
the Drug Review Center of the State Drug Administration shall organize experts to conduct technical reviews in accordance with the drug market licensing review procedures stipulated in the Measures for the Administration of Drug Registration.
3. Transition period for the registration and declaration of Chinese medicine: If an application for registration of Chinese medicine has been accepted and the registration classification needs to be adjusted, the applicant may withdraw the application and re-report according to the new registration classification and declaration information requirements, and no additional fees shall be charged.
by 31 December 2020, applicants may submit their declarations in accordance with the new requirements, or they may submit their declarations in accordance with the original requirements.
4, the implementation period of this requirement: from January 1, 2021, all in accordance with the new requirements to submit the declaration information.
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