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

ABSTRACT

OBJECTIVE：To pr ovide 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.