Skip to main content

Table 1 Relevant policy documents for Chinese Classical Formulas pharmaceutical preparations

From: The key issues and development strategy of Chinese Classical Formulas pharmaceutical preparations

No Time Documents Main contents
1 2008.01 Supplementary Provisions by the Administration of Registration of Chinese Medicines Three principles, exempt from clinical trials, no certificate for new drugs
2 2015.08 Opinions on Reforming the Review and Approval System for Drugs and Medical Devices Simplified the approval process
3 2016.02 Outline of the Strategic Plan for the Development of Traditional Chinese Medicine Encourage the development of classical Chinese medicine prescriptions
4 2016.12 Law of the People's Republic of China on Traditional Chinese Medicine Article 30: Comply with national regulations and provide non-clinical safety research data
5 2017.03 The Selection Scope and Selection Principles of the Formulation of the Ancient Chinese Classical Formulas (CCF) Catalog 4 Selection principles
6 2017.10 Opinions on Reforming the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices Article 13: Review and approve in accordance with simplified standards
7 2017.10 Simplified Registration and Approval Management Regulations for Chinese Classical Formulas pharmaceutical preparations (CCFPP) (draft for comments) Simplified the approval process for CCFPP
8 2017.10 Application data requirements for standard decoction of Chinese Classical Formulas pharmaceutical preparations (draft for solicitation of comments) Standard decoction related information should be provided
9 2017.10 Requirements for the application materials of Chinese Classical Formulas pharmaceutical preparations (draft for soliciting comments) Exempt drug effect tests and clinical trials
10 2017.10 Technical Guiding Principles for the Evaluation of Chinese Medicine Resources Estimated consumption, potential risks and sustainable use measures
11 2018.04 The State Administration of Traditional Chinese Medicine, in conjunction with the State Drug Administration, announced the "Catalogue of Ancient Classic Prescriptions (First Batch)" Release the first batch of CCF (100 CCFs)
12 2018.05 Simplified Registration and Approval Management Regulations for Ancient Chinese Classical Formulas pharmaceutical preparations Material benchmark, key quality attributes
13 2019.03 Application Requirements of Ancient Chinese Classical Formulas pharmaceutical preparations and Substance Standards File a data declaration request
14 2020.04 Special Regulations on Registration and Management of Chinese Medicines (Draft for Solicitation of Comments) Accelerate the promotion of Chinese Medicine Innovation
15 2020.09 Classification of Chinese Medicine Registration and Filing Requirements Ceased review and release the unified standard of "Classic Named Substance Standards"
16 2020.10 "Key Information Principles of Ancient Classical Prescriptions" (7 Prescriptions)" Rendered related requirements of key Information
17 2020.11 Technical Guidelines for Research on Homogenization of Traditional Chinese Medicine Ensure uniformity and stability of product
18 2021.04 Technical Guidelines for Pharmaceutical Research on Chinese Classical Formulas pharmaceutical preparations administered in accordance with the ancient famous prescriptions (Draft for Solicitation of Comments) Technical Guidelines for Pharmaceutical Research on CCFPP