Problems analysis and policy interpretation of changes to batch for chemical drug under the new regulations
Objective This paper can provide reference for relative parties to carry out batch change research,based on analyzing the problems,the status quo and interpretating the policy in the process of batch change.Methods This paper deeply interpreted batch change of Technical Guideline for Making Post Approval Changes to Chemical Drug Products(Trial Implementation),and summarized the common problems and the status quo in the batch change of listed chemical drug in Shandong province.Results As the batch change added after the implementation of Technical Guideline for Making Post Approval Changes to Chemical Drug Products(Trial Implementation),batch change is usually relative to many aspects of the production process,such as equipment,process,parameters,solvent ratio and so on.Although the post-approval chemical drugs pass rate of the batch change is increased,but the understanding of the regulatory documents in applicants still needs to be improved.Conclusion The implementation of the New Regulations provid legal support for the application of new technology and new equipment,expanding production capacity,improving competitive advantage.As the main body of listed drug change researches,marketing authorization holders should pay more attention to associated changes in batch change,conduct change research more scientifically.
Listed chemical drugChange managementBatch changeNew Regulations
国家科技期刊平台
NSTL
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