MAH制度下放射性药品CDMO行业探究

The Research Progress on CDMO Industry of Radiopharmaceuticals Under MAH System

近年来,随着国内外放射性药品市场需求的提升,国内以注册为目的放射性药品研发开始逐渐增多,带动国内放射性药品CDMO行业发展。MAH制度下放射性药品CDMO如何适应监管政策的变化及行业要求,是其发展必须面对的问题。基于此,本文依据《药品管理法》、《放射性同位素与射线装置安全和防护条例》等相关制度的要求,对放射性药品CDMO建立的难点进行综述分析,归纳总结放射性药品CDMO行业政策法规要求及行业特点,阐明我国上市许可持有人制度下建立放射性药品CDMO的难点和对策,以期为涉足或者打算涉足放射性药品CDMO的企业提供参考。

In recent years,with the ascension of radiopharmaceuticals market demand at home and abroad,while the domestic research and development of radiopharmaceuticals for registration purposes began to increase gradually,which drove the development of the domestic radiopharmaceuticals CDMO industry.How the radiopharmaceuticals CDMO adapt to these changes in regulatory policies and industry requirements under the MAH system is becoming an issue.In light of this,according to the requirements of“Drug Administration Law”,“Regulations for Safety and Protection Against Radioisotopes and Radiation-Emitting Apparatus”and other relevant systems,we overview and analyze the difficulties in the establishment of CDMO for radiopharmaceuticals,and summarize the policies,regulations,requirements and industry characteristics of CDMO for radiopharmaceuticals,so as to clarify the difficulties and countermeasures of establishing CDMO for radiopharmaceuticals under the system of marketing license holders in China,in order to provide a reference for enterprises involved in or intending to involve CDMO for radiopharmaceuticals.