Based on the deepening awareness of the risk of changing packaging materials of injections,the national regulatory authorities and the China National Pharmaceutical Packaging Association have issued the relevant guide...Based on the deepening awareness of the risk of changing packaging materials of injections,the national regulatory authorities and the China National Pharmaceutical Packaging Association have issued the relevant guidelines and group standards for changing packaging materials in recent years,greatly improving the research and development and technical requirements of packaging materials of injections.In 2021,Guangdong Province carried out the archival examination of the change of listed drugs,among which the proportion of the acceptance of changed injection packaging materials has increased year by year.On the basis of sorting out the archival examination work and combining with the cases of changing packaging materials of chemical injections accepted by Guangdong Province during 2021-2022,the requirements and problems of archival examination were analyzed and discussed to provide a reference and idea for applicants when studying the change in packaging materials.展开更多
基金Supported by the Research on the Archival Examination Strategy of changes in Listed Drugs Based on Risk under the Guidance of Holders'Principal Responsibility(2023TDZ01)。
文摘Based on the deepening awareness of the risk of changing packaging materials of injections,the national regulatory authorities and the China National Pharmaceutical Packaging Association have issued the relevant guidelines and group standards for changing packaging materials in recent years,greatly improving the research and development and technical requirements of packaging materials of injections.In 2021,Guangdong Province carried out the archival examination of the change of listed drugs,among which the proportion of the acceptance of changed injection packaging materials has increased year by year.On the basis of sorting out the archival examination work and combining with the cases of changing packaging materials of chemical injections accepted by Guangdong Province during 2021-2022,the requirements and problems of archival examination were analyzed and discussed to provide a reference and idea for applicants when studying the change in packaging materials.
