2160 ‐（株）ジーエヌアイグループの掲示板

>>9086

英語のままで申し訳ございませんが。。。下記参考になるかと存じます。

[总局关于鼓励药品创新实行优先审评审批的意见] 2017-12-28
Opinions of the General Administration on Encouraging Drug Innovation to Implement Priority Review and Approval
http://samr.cfda.gov.cn/WS01/CL0844/220706.html

First, the scope of priority review and approval
(1) Application for registration of a drug with obvious clinical value and one of the following conditions: 
　　1. Application for registration of innovative drugs not listed and sold in China. 
…
7. Included in the National Science and Technology Major Project, the National Key R&D Program, and the application for registration of new drugs approved by the National Center for Clinical Medical Research and approved by the Central Management Department.
　　Drug registration application (b) controlling the following diseases with obvious clinical advantages: 
　　1. AIDS; 
　　2. tuberculosis; 
　　3. viral hepatitis; 
　　4. rare disease; 
　　5. malignancies; 
　　6 children with drugs; 
　　7. elderly Endemic and multiple diseases.


Second, the process of priority review and approval
…After the completion of Phase I and Phase II clinical trials, the applicant submits the trial results and the next clinical trial protocol in a timely manner. The drug review center arranges communication with the applicant within 30 days after receiving the information. If no safety problems are found, they can be transferred to the next clinical trial after communicating with the drug trial center. For the results of the trials showing no better than the trend of the listed drugs, no priority will be given. 
　　For rare diseases or other special diseases, you can apply for a reduction in the number of clinical trial cases or exemption from clinical trials when applying for clinical trials. The drug review center makes a decision on whether to approve the application based on the technical review needs and the actual situation of the Chinese patient. 

…4. For the treatment of serious life-threatening diseases, there is no effective treatment, and new drugs that are of great significance for solving clinical needs. Applicants can submit an application for face-to-face communication with the drug testing center at any time after preparation. The reviewers should Schedule a meeting to exchange views within 10 days. In the clinical trial phase, the drug trial center should maintain communication with the applicant to guide and promote the development of new drug clinical trials; if based on early clinical trial data, it can reasonably predict or judge its clinical benefit and is more obvious than existing treatment methods. The advantage allows for conditional approval of the market prior to completion of the Phase III confirmatory clinical trial.

参考(英語):
https://www.fdanews.com/IPRM0325162
https://www.slideshare.net/MarcusEvansPharma/discovering-key-regulatory-reforms-to-enable-accelerated-drug-development-and-approval-in-china-dr-ye-hua