The National Medical Products Administration deploys work to improve the conditional approval system for drugs

People’s Finance News, March 30—On March 27, Li Li, Party Secretary of the State Drug Administration and Director, presided over a meeting to study and deploy plans to improve the drug conditional approval system, and to deliberate and adopt the “Administrative Procedures for the Review and Approval of Applications for Conditional Approval for Drug Marketing (Revised Draft)” (hereinafter referred to as the “Procedures”).

The meeting pointed out that conditional approval for drug marketing is a new system within drug registration and administration. Since the implementation of the system, it has played an important role in accelerating the launch of drugs to treat critical illnesses with no effective treatment methods in clinical settings, among other areas, and has provided important support for addressing urgent clinical needs in treatment fields such as oncology. With the rapid development of homegrown, independent innovation in drug research and development in China, it is currently necessary to further optimize and improve the system based on work practice, drawing on international experience, and in light of industry demands.

The “Procedures” further clarify the approval criteria for conditional drug listings, the measures for handling cases where post-marketing research is not completed on schedule, and the requirements for re-registration management of drugs approved under conditions, as well as the requirements for generic-drug applications and changes of holders.

The introduction of the “Procedures” is of great significance for further strengthening the management of drugs approved under conditions, accelerating the marketing of more new drugs urgently needed in clinical settings, prompting holders to implement the conditional requirements, and protecting patients’ medication rights and interests. It is an important step for the drug regulatory authorities to implement the development philosophy of putting the people first.

The meeting agreed that the “Procedures” be released and implemented shortly. The State Drug Administration will strengthen overall coordination, continue to do a good job in the review and approval of drugs under conditional approval, further increase communication and guidance for enterprises, and at the same time actively carry out outreach and interpretation, address concerns from the industry, and ensure that the relevant institutional arrangements take effect effectively.