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The CFDA will reform the drug approval system to improve approval efficiency.
Release time:
2014-10-31
According to the overall deployment of the central government to deepen reforms, the CFDA plans to maximize the policy synergy effect and improve the efficiency of review and approval by reforming the drug acceptance model.
CFDA will reform the drug approval system to improve approval efficiency.
The summary is as follows.
In accordance with the overall deployment of the central government to deepen reforms comprehensively, CFDA plans to maximize the policy synergy effect and improve the efficiency of review and approval by reforming the drug acceptance model and other measures.
On October 9, 2014, the National Medical Products Administration held a symposium on key suggestions from the second session of the 12th National People's Congress. The meeting informed some national representatives from the pharmaceutical industry about the reform of the drug review and approval system, which is of general concern in the industry, and once again listened to the suggestions and opinions of national representatives as well as the General Office of the National People's Congress, the Education, Science, Culture and Health Committee of the National People's Congress, the General Office of the State Council, and various relevant ministries.
In 2014, the National People's Congress included the reform of the drug review and approval system as one of the 18 key suggestions to be addressed, which was assigned to the National Medical Products Administration in conjunction with the Central Organization Department, the National Development and Reform Commission, and the Ministry of Finance. To effectively address the key suggestions, the Administration held a special symposium to hear the opinions of national representatives on the handling of key suggestions.
The national representatives present at the meeting provided constructive opinions and suggestions on food and drug regulation work, especially on the reform of the drug review and approval system. One national representative stated, "I have served as a national representative for four terms, and this time the Administration and relevant departments' handling and response to key suggestions is the most satisfactory for me! I hope the reform of the drug review and approval system can be implemented as soon as possible to solve issues such as the backlog of drug reviews and approvals." Another national representative suggested, "The pace of reform should be greater! While increasing the number of review and approval personnel, it is suggested to adjust the management of drug registration fees, try third-party purchasing services, and allocate personnel and arrange salaries according to market principles." Another representative suggested, "We should further improve and adjust the drug review strategy, select drugs for priority review, and expedite the approval of drugs for major diseases, rare diseases, and diseases affecting the elderly and children."
Currently, the drug review and approval work faces issues such as long drug approval cycles, insufficient personnel and technical capabilities in review institutions, unreasonable division of responsibilities, and the need to improve the priority review mechanism, which do not align with the central government's requirements to strengthen and improve people's livelihoods, nor with the growing public health needs and the promotion of innovation and development in the pharmaceutical industry.
In accordance with the overall deployment of the central government to deepen reforms comprehensively, the National Medical Products Administration plans to reform key aspects such as the drug acceptance model, technical review management system, and administrative approval management methods, as well as enhance technical review capabilities and streamline funding and fee management measures, to maximize the policy synergy effect and improve review and approval efficiency. The Administration will further strengthen communication with national representatives and members of the Chinese People's Political Consultative Conference, widely adopt relevant opinions and suggestions, and jointly accelerate the reform of the drug review and approval system, effectively addressing the bottleneck issues that restrict review and approval work, and comprehensively enhancing drug safety governance capabilities and public health protection levels.
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