Food and Drug Administration launched the drug approval system reform time has not yet been disclosed


Release time:

2014-10-29


Within one month, the State Food and Drug Administration twice proposed to reform the current drug review and approval system. Various signs indicate that the comprehensive reform of the drug review system criticized by domestic and foreign pharmaceutical companies has been included in the agenda and will be released soon.
Wu Zhen, deputy director of the General Administration of Food and Drug, revealed at the "Symposium on the Handling of Key Recommendations of the Second Session of the Twelfth National People's Congress" on October 9 that the General Administration of Food and Drug intends to reform the drug acceptance model, technical review management system, and administrative approval management. And other key links, as well as reform safeguard measures such as enriching technical review forces, straightening out funding and fee management methods, maximize the superimposed effect of policies, and improve the efficiency of review and approval.
On October 24, the Party Group of the General Administration of Food and Drug learned to convey the main spirit of the Fourth Plenary Session of the 18th Central Committee, requesting to speed up the reform of the drug and medical device review and approval system, and to reform the process, reform fees, reform personnel management, and implement government purchase services., To revise relevant laws and regulations, so that reforms can be linked with legislation.
A reporter from the Economic Information Daily learned that in 2014, the National people's Congress took the reform of the drug review and approval system as one of the 18 key suggestions, which were handed over to the State Food and Drug Administration in conjunction with the Central editorial Office, the National Development and Reform Commission and the Ministry of Finance. Some representatives of the National People's Congress of the pharmaceutical industry told the reporter of the Economic Information Daily that my country's current drug review system has low approval efficiency, low entry barriers, and no introduction of market mechanisms. On the one hand, it has seriously hindered the development of new drugs by domestic pharmaceutical companies, and on the other hand, it indirectly leads to Patients do not use new drugs and cheap generic drugs. In addition, despite the introduction of national policies to open up a green channel for innovative drugs, but the progress is not smooth.
The National Drug Evaluation Center has a staff of 120 according to the national allocation, but only 80 of them are engaged in first-line evaluation. Relevant personnel of the National Drug Evaluation Center said that because the drug evaluation center is treated according to the public participation personnel, the income is too low to retain high-end technical personnel.
In addition to the shortage of manpower, the slow speed of drug approval is also due to the low level of application documents and the serious situation of repeated application. The 2013 Drug Review Report shows that in 2013, the Drug Review Center accepted 7529 new registration applications throughout the year, but 4491 review tasks were completed and submitted to the State Food and Drug Administration for approval. The difference between the accepted amount and the completed amount was 3038, and only 60% of the new drug applications were reviewed.
As for the time when the opinions on the reform of the drug review system were issued, the relevant person of the Food and Drug Administration did not disclose it. He only mentioned that the General Administration of Food and Drug Administration should promptly revise and improve it before reporting it to the State Council for approval, and study and put forward operational measures to optimize the review and approval process and improve the efficiency of review and approval.
However, a reporter from the Economic Information Daily noted that the General Administration of Food and Drug issued the first batch of excessively repetitive Drug varieties catalogue in mid-September, reminding social investors and relevant enterprises for the first time to pay attention to assessing R & D risks and making investment and management decisions carefully.
A relevant person from the Food and Drug Administration said that in the next step, according to the drug registration approval situation, we will continue to improve the drug registration information release system, effectively guide the establishment and topic selection of drug research and development, and transfer limited resources to innovative drugs with clinical value and clinical urgent needs. The review and approval of generic drugs is tilted to avoid a large number of repeated research and development and waste of resources.