Discussion and Suggestions on Problems in Variation Research of Chemical Drug Excipients in Shandong Province
Objective To analyze the common problems in variation research of pharmaceutical excipients of post-approval chemical drug products in Shandong Province,in order to reduce the risks of variation research and improve the standardization of variation application.Methods Based on the requirements of current relevant laws,regulations,and guiding principles,combined with the industry status and technical review experience,the common problems in the filing and application process in Shandong Province were analyzed,and the thoughts and discussions on the problems were put forward.Results There were still problems with the identification and classification of variation of pharmaceutical excipients for post-approval chemical drugs in Shandong Province,as well as filling of content for record and publicity,supply of supporting materials and comparison of functional indicators of pharmaceutical excipients,research and validation data,and stability research,etc.Conclusion It is recommended that Marketing Authorization Holders fulfill their principal responsibility,pay attention to the research of pharmaceutical excipients from the research and development stage,scientifically evaluate verification of excipients,conduct comprehensive verification research,thus ensure the quality and efficacy of drugs throughout their entire life cycle.
post-approval chemical drug productpharmaceutical excipientpost-approval variationresearch and validation
万方数据
维普
