According to the official website of the National Medical Products Administration, on March 27th, Li Li, Secretary of the Party Group and Director of the National Medical Products Administration, presided over a meeting to study and deploy the improvement of the drug conditional approval system, and approved the "Work Procedure for the Review and Approval of Drug Conditional Approval for Market Applications (Revised Draft)" (hereinafter referred to as the "Work Procedure"). The meeting pointed out that conditional approval for drug listing is a new system in drug registration management. Since the implementation of this system, it has played an important role in accelerating the market launch of critical illness drugs for which there is currently no effective treatment method in clinical practice, providing important guarantees for addressing the urgent clinical needs in the field of cancer and other treatments. With the rapid development of independent innovation and research and development of drugs in China, it is necessary to further optimize and improve the system based on work practice, draw on international experience, and combine industry demands. The Work Procedure further clarifies the approval criteria for conditional drug listing, the handling measures for failure to complete post market research on schedule, as well as the requirements for re registration management, replication, and holder change of conditionally approved drugs. The introduction of the "Work Procedure" is of great significance for further strengthening the management of conditionally approved drugs, accelerating the launch of more clinically urgently needed new drugs, urging holders to implement conditional requirements, and protecting patients' medication rights and interests. It is an important measure for drug regulatory authorities to implement the people-centered development concept. The meeting agreed to release and implement the 'Work Procedure' in the near future. The National Medical Products Administration will strengthen overall coordination, continuously carry out conditional drug review and approval, further increase communication and guidance to enterprises, and actively promote and answer industry concerns to ensure the effective implementation of relevant institutional arrangements. (New Society)
Edit:WENWEN Responsible editor:LINXUAN
Source:people.com
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