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

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

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:在定义方面,药品生产许可延续是指药品生产企业如果还需要在其药品生产许可证有效期届满后继续从事药品生产有关活动的,应当在有效期届满前六个月,向省级药品监督管理部门申请延续其药品生产许可证有效期的行为。在主要问题方面,主要存在行政机关是否可以受理相对人逾期提交的申请不明确、行政机关换发药品生产许可证的审查标准不合理、“视为同意换证”模式许可规则的后续程序不规范等问题。新修订《药品生产监督管理办法》规定,药品生产许可证的换发不再需要按照药品生产企业开办的程序和要求进行审查,而是根据风险管理原则进行审查。这些修订内容体现了强化风险管理、形成风险闭环的原则,明确了药品生产许可延续的审查标准,优化了审批条件和要求,提高了行政许可的效率。在适用情形方面,建议明确药品生产许可延续受理与决定的时限和有效性,赋予行政机关对逾期延续申请受理的自由裁量权。

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.