China CDE has issued an updated version of “Administrative Measures for Drug R&D and Technical Review Communication and Discussion ” on 11 December 2020 to further standardize communication with applicants and established a multi-channel and multi-level communication mechanism to encourage the research and development and registration of innovative drugs, accelerate the speed of market launch, and promote the positive development of the industry.
Following drug development and registration requirements, and based on the principle of benefiting drug registration applicants, the main revisions include the following three aspects:
1) Adjust and optimize communication procedures
2) Standardize and refine communication requirements
3) Optimize and refine the communication scenarios
The communication referred to in the updated document refers to the communication between the applicant and the review team of the Center for Drug Evaluation on key technical questions that cannot be covered by the current drug development and evaluation guidelines
The communication meeting is to be proposed by the applicant, and jointly discussed between the project management personnel of the Center for Drug Evaluation and the drug registration personnel designated by the applicant and will be held after CDE agrees.
The forms of communication include: face-to-face meetings, video meetings, teleconferences or written responses. Applicants are encouraged to communicate with the CDE through telephone conferences. The proposal, negotiation, and conduct of communication, as well as the preparation, convening, recording and summary of relevant meetings, shall all comply with these Measures.
Scope is applicable to Chinese medicine, chemical entities and biological products and their R & D process and registration application technical review.
During the communication process, the applicant and the review team can fully elaborate their views on the issues discussed, and the consensus formed can be used as an important reference for R&D and evaluation.
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