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      In order to fully implement the“Opinions on comprehensively deepening the regulatory reform of drugs and medical devices to promote the high-qualitdevelopment
of the pharmaceutical industry”(GUOBANFA [2024] No. 53) and further improve the efficiency of pre-review of clinical trial programs, to effectively

promote the clinical translation of innovative technologies, matters related to the pre-review of clinical trial protocols are now further clarified as follows:

    1. he applicant shall submit an application for pre-review of the clinical trial protocol through the consultation and communication pathway for major technical issues
 of innovative products opened by the Device Review Center, and in the title clearly the application for“× × × (product name) clinical trial protocol pre-review.”

    2. The applicant shall ensure that an application for pre-review of a clinical trial protocol is submitted on completion of the necessary non-clinical studies
and, if necessary, a clinical trial feasibility study. Clinical trial protocols should be scientifically validated and developed on the basis of full consideration of product characteristics,
clinical risks, and available clinical data.

    3. The applicant shall submit a review of the subject matter, necessary non-clinical research data, clinical trial protocols, and relevant supporting information as required
in annexes 1 and 2. The information should be able to clarify the scope of application/intended use, working principle/mechanism of action/test principle, structural composition/main
components and material information (if applicable) , etc. , identify the key functional and performance parameters of the product and fully demonstrate the acceptability of the intended clinical risk.    

    4. The device examination center will review the relevant materials of the pre-examination application. If after review, it is found that the submitted materials do not meet the above requirements, the review department can feedback the applicant through video conference and other means, and inform the applicant that the clinical trial protocol can not be confirmed this time, a pre-review of the clinical trial protocol will be conducted after the applicant has resubmitted the application and provided the required additional research data. If the applicant is satisfied that the submitted data meet the requirements, a pre-review of the clinical trial protocol will be conducted, if necessary, an expert consultation meeting can be held, and the applicant should cooperate with the relevant work, and introduce the basic situation of product design and development and clinical trial scheme design in detail in the communication and consultation meeting.

    5. Based on the current scientific understanding or clinical consensus, the center provides pre-review opinions on the clinical trial protocol or clinical trial design requirements, and gives feedback to the applicant in an appropriate manner. It is recommended that applicants conduct clinical trials in accordance with the pre-review opinion, and if there are program adjustments, the increased risks and uncertainties should be fully considered.
    
    6. If there are significant changes in product design or technical characteristics after the pre-review of clinical trial protocol (but it does not affect the recognition of product innovation points) , it is recommended to re-review the clinical trial protocol.

    7. The opinions of pre-review of clinical trial protocol shall serve to guide the applicant to carry out the design of clinical trial scientifically, and shall not be regarded as the opinions and conclusions of technical review.

    This is to inform you.