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 |