问答式审评体系在药品技术转让审评的应用探索

Question-based review application exploration in drug technology transfer evaluation

目的探索问答式审评质量评价体系(QbR)在药品技术转让审评的应用。方法识别现有药品技术转让的审评过程的核心问题,结合现有我国药品技术转让的法规和相关技术指导原则要求,制定药品技术转让审评提问问题提纲。结果与结论通过借鉴和吸取问答式审评质量评价体系的优点和长处,可以提高药品技术转让审评的质量与效率。

Objective To explore the application of Question-Based Review in drug technology transfer evaluation.Methods First of all,identify core issues in the review for drug technology transfer;Second,combined with the laws and related technical guidelines on drug technology transfer in China;The last,formulate the model quality overall summaries for drug technology transfer review.Results and Conclusion The quality and efficiency of drug technology transfer evaluation can be improved by drawing on the advantages of QbR.