《按古代经典名方目录管理的中药复方制剂药学研究技术指导原则(试行)》简介

Introduction of Guidance on CMC of Traditional Chinese Medicine Compound Preparations Developed from Catalogued Ancient Classical Prescriptions(Interim)

为支持古代经典名方的研发,古代经典名方相关的鼓励性政策先后发布,行业的研发热情日渐高涨。本文主要介绍了《按古代经典名方目录管理的中药复方制剂药学研究技术指导原则(试行)》起草的相关历史背景和政策法规依据,总结了按古代经典名方目录管理的中药复方制剂(即中药3.1类)药学研究中存在的主要问题,阐述了指导原则的起草思路,以便于业界深入理解相关技术要求,同时提出了相关的研究建议,以期推进中药3.1类的研发、保障药物的质量,传承好中医药的精华。

In order to support the research and development of Ancient Classical Prescriptions(ACP),a number of incentive policies related to ACP have been released successively,generating increasing enthusiasm from industry for research and development of ACP.This paper mainly introduces the relevant background and regulatory basis for drafting the Guidance for CMC of Traditional Chinese Medicine Compound Preparations Developed from Catalogued Ancient Classical Prescriptions(Interim),summarizes the main challenges with CMC for traditional Chinese medicine compound preparations(TCMCP)developed from Catalogued Ancient Classical Prescriptions(CACP)(known as Category 3.1 TCM),elaborates the underlying ideas for the guidance,so that industry will better understand relevant requirements in this guidance.This paper also puts forward suggestions on drug development and registration with a view to promoting development of Category 3.1 TCM and ensuring the quality of TCM products and inheritance of TCM treasures.