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On April 18, CDE publicly issued a notice soliciting opinions on the "Technical Guidelines for Drug Clinical Dependence Research (Draft for Comment)"
Main contents: The core contents of the clinical dependence research plan are introduced respectively: the research subjects have identified three situations that require clinical dependence assessment; the research timing introduces when clinical dependence assessment needs to be conducted for drugs with potential of abuse, and Link to non-clinical dependence research; research methods specifies methods for assessing clinical dependence on drugs, including abuse-related adverse event collection, cognitive and behavioral testing, physical dependence (withdrawal) assessment, and human abuse potential studies
Drug clinical dependence research is an important pre-market research content for new drugs with potential abuse risks, and there is no specialized technical requirement for standardized management of such research in China
We sincerely welcome valuable comments and suggestions from all walks of life on the draft, and timely feedback to us for subsequent improvement
Please send your feedback to the following email:
Contact: zhanghao@cde.
Thank you for your participation and great support
Center for Drug Evaluation, State Drug Administration
April 18, 2022
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