Events
On February 22, CDE released the working procedures of the drug review center for accelerating the review of innovative drug listing applications (Trial) (Draft for comments).
Commentary
The purpose of this release is to encourage the research and creation of new drugs, meet the needs of clinical medication, timely summarize the experience of emergency review of transformation and anti epidemic, and speed up the review of innovative drugs. CDE shows that in early 2020, covid-19 pneumonia broke out. Under the leadership of the Party group of the National Bureau, the drug examination center immediately established a leading group and working group, formulated a work plan, clarified the work procedures and processes, and started the covid-19 emergency review and approval, which achieved phased results. In order to further encourage innovation, meet clinical needs and transform anti epidemic experience and achievements, the drug trial center organized and drafted the working procedures for accelerating the review of innovative drug listing application (Trial) of the drug trial center, so as to transform, consolidate and expand anti epidemic achievements in the form of system.
For breakthrough therapeutic drugs, simplify the application priority review and approval process. The accelerated procedure released this time is applicable to innovative drugs included in the breakthrough treatment drug procedure. Compared with the original 2020 drug registration management measures, the procedure is further simplified. According to the original registration management measures, drugs included in the breakthrough treatment drug procedure can apply for the priority review and approval procedure when applying for drug marketing license. If they are included in the priority review and approval procedure, the review time limit of marketing application is 130 days. Under the new working procedures, innovative drugs incorporated into the breakthrough therapeutic drug program can automatically carry out follow-up communication, review and approval according to the new accelerated procedures. The time limit for communication and exchange is 30 days, and the time limit for variety review is 130 days compared with that for priority varieties.
Clarify the content and time limit of communication, and improve the efficiency and success rate of R & D. In addition to the routine communication before the application for marketing license, the accelerated procedure points out that after completing the preliminary exploratory clinical trial, the applicant can apply for communication before and during the key clinical trial, and the drug trial center and the applicant can submit plans for follow-up communication and exchange plans, phased research materials Discuss and reach an agreement on the submission plan of drug marketing license application. And in the follow-up work, continue to connect and guide with the applicant, and intervene in advance to guide the application materials. The communication application shall be submitted as class I meeting, which is generally held within 30 days after the application. Strengthening the communication between enterprises and CDE in the R & D process of innovative drugs is conducive to designing clinical trial schemes that meet the application requirements, speeding up the R & D time, making full use of clinical resources, and improving the R & D efficiency and success rate.
Specify that the expert consultation meeting shall be held as required without affecting the review time limit. In the process of professional review and comprehensive review, if it is necessary to hold an expert consultation meeting after the discussion of the professional technical committee of the professional department, the professional review department can propose to hold the meeting through the internal request of the center under the condition of ensuring the professional time limit. Holding an expert consultation meeting is conducive to listening to expert suggestions and quickly making decisions that are most conducive to solving the actual clinical needs in combination with clinical practice.
CDE has given strong support to breakthrough therapeutic drugs from the approval end, and is optimistic about innovative drug R & D enterprises, especially those with differentiated innovation ability, which can develop innovative drugs with serious consequences of disease prevention and treatment and no effective treatment.
Investment advice
Optimistic about innovative pharmaceutical enterprises in the head, it is suggested to pay attention to: Shanghai Junshi Biosciences Co.Ltd(688180) , Kingsley biotechnology, Jiangsu Hengrui Medicine Co.Ltd(600276) , Baiji Shenzhou, Sinocelltech Group Limited(688520) , etc.
Risk tips
The risk of new drug R & D failure, the risk of investment and financing lower than expected, the risk of intensified competition between China and overseas markets, the risk of medical insurance negotiation lower than expected, the risk of industrial regulatory policies, etc.
