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Four major changes on drug registration management measures

ECHEMI 2020-04-07

 On March 30, the State Administration of market supervision promulgated the measures for the administration of drug registration by order No. 27 of the State Administration of industry and the measures for the administration of drug production by order No. 28 of the State Administration of industry and commerce, and the two regulations will come into force on July 1, 2020.


Focus on four changes. According to the two regulations just released, the main contents of the changes include: first, fully implement the system of drug marketing license holders. It is clear that the applicant is an enterprise or drug research and development institution that can bear the corresponding responsibilities, and it is required to establish a drug quality assurance system, manage the whole life cycle of drugs, carry out post marketing research, and bear the safety, effectiveness and quality responsibilities of listed drugs.


Second, optimize the review and approval process. We will do a good job in the connection of the acceptance, review, verification and inspection of drug registration, change the original review, verification and inspection from "series" to "parallel", set up four acceleration channels: breakthrough treatment drugs, conditional approval, priority review and approval, and special approval, clarify the review time limit, and improve the efficiency of drug registration and the expectation of the registration time limit. According to the principle of risk management, implement the requirements of "release management service", and implement classified management for changes.


Third, implement the requirements of life cycle management. We will strengthen drug development, registration and post market supervision. Increase the requirements for the supervision of non clinical drug research institutions, clinical drug testing institutions and drug safety credit files. Pay attention to the organic connection between registration and production license, implement the standard requirements of drug production quality management, and clarify the inspection procedures and follow-up treatment measures of inspection results. Actively promote social co governance, and require public review of conclusions and basis, accept social supervision.


Fourth, strengthen accountability. We will refine penalties, crack down on data fraud and other violations, and create a good environment for innovation. In general, as the core supporting regulations in the field of drug supervision, the revision of these two regulations will lay a legal foundation for strengthening drug quality and safety risk control, standardizing and strengthening drug supervision, and ensuring drug safety, effectiveness and quality control.

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