中药新药临床有效性评价法规变化的浅析

Regulation changes in the clinical efficacy evaluation of Traditional Chinese Drug

本文梳理现行法规与原法规,总结了现行法规有效性方面有三个变化关键点:"主治为证候的中药复方制剂"、"主治为病证结合的中药复方制剂"和"对照的要求"。并对相关条文进行了解读,提出个人对法规变化的理解以及可能存在的挑战和对策。

The original and current regulations were reviewed.Three key points of regulation changes in efficacy evaluation were summarized,such as indications for the syndromes of Traditional Chinese Medicine,Traditional Chinese medicine for the disease and syndrome,and the requirements of control group.The related articles were interpretation,the challenges and counter-measurements were built up.