对新修订《药品生产监督管理办法》中药品生产许可延续条款的评析和建议

目的:为有关部门进一步明确药品生产许可延续的定义和适用规则、加强药品生产监督管理提供参考.方法:通过对比研究、文献研究、实证研究与新规章的解读,从药品生产许可延续的定义出发,结合实际案例和基层实践,对《药品生产监督管理办法》中药品生产许可延续的定义、存在问题、修订要点等方面进行全面评析,并提出相应适用建议.结果 与结论...

Comment and Suggestion on the Renewal Clause of the Drug Production License in the Newly Revised Measures for Supervision and Administration of Pharmaceutical Production

OBJECTIVE:To provide reference for the relevant departments to further clarify the definition and applicable rules of drug production license renewal,and strengthen the supervision and administration of drug production.METHODS:Through comparative study,literature study,empirical study and the interpretation of new regulations,from the definition of drug production license renewal,combined with actual cases and grass-roots practice,drug production license renewal in the Measures for Supervision and Administration of Pharmaceutical Production were comprehensively evaluated and analyzed in terms of the definition,existing problems and revision points.The relevent application suggestion was put forward.RESULTS&CONCLUSIONS:In terms of definition,the renewal of the drug production license refers to the behavior of a drug manufacturer that needs to continue to engage in drug production activities after the expiration of the validity period,and should apply to the original issuing authority to extend the validity period of the drug production administrative license at 6 months before the expiration of the validity period.In terms of the main problems,there are some problems,such as whether the administrative organ can accept the application submitted after the deadline is not clear;the examination standard of the administrative organ to renew the drug production license is unreasonable;the follow-up procedure of the license rule of the“deemed to agree to renew the license”mode is not standardized.The renewal of the drug production license in the newly revised Measures for the Supervision and Administration of Pharmaceutical Production no longer needs to be reviewed in accordance with the procedures and requirements of the drug manufacturer,but in accordance with the principles of risk management,which reflecting the principle of strengthening risk management and forming risk closed-loop,defining the review standard of drug production license renewal,optimizing the conditions and requirements of approval,and improving the effectiveness of administrative license.In terms of application,it is suggested to clarify the time limit and validity of the acceptance and decision of drug production license renewal,and grant administrative agencies with the discretion to accept the application for overdue renewal.