《已上市化学药品药学变更研究技术指导原则(试行)》制剂处方中辅料变更的解读

Interpretation of Changes to Excipients in Drug Product Formulation according to Technical Guideline for Making Post Approval Changes to Chemical Drug Products(Trial Implementation)

《已上市化学药品药学变更研究技术指导原则(试行)》发布实施后,如何对已上市化学药品的药学变更进行分类和研究,成为行业内普遍关注的问题。变更制剂处方中的辅料是该指导原则中一个重要的章节,本文从变更辅料的种类、用量、技术等级、供应商、质量标准等5个方面对如何进行变更分类进行归纳总结,对各项变更分类的研究工作进行了列表对比,说明了需要重点关注的事项,并结合审评工作实际补充了指导原则中未明确的部分内容。以帮助相关单位更好地理解指导原则,更科学地进行变更研究,也为监管机构提供参考,从而推动行业的发展。

After the publication and implementation of Technical Guideline for Making Post Approval Changes to Chemical Drug Products(Trial Implementation), how to classify and study post approval changes to chemicals becomes a common concern in the pharmaceutical industry, and changes to excipients in drug product formulation is an important chapter in this guideline. This paper summarizes how to classify changes to excipient type, excipient amount, item code or grade, supplier, and quality standard from a total of five aspects, compares tabularly the research work of each change classification, explains the matters needing attention, and supplements some contents not specified in the guideline in combination with the actual review work, which helps the relative parties better understand the guiding principles and conduct change research more scientifically, provides references for regulatory agencies, and then promotes the development of the industry.