Research Ⅱ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:The Enlightenment of EU Requirements for Drug Clinical Trials and Change Management during Clinical Trials on Improving China's Regulatory System
Objective:To provide reference through comparative research and analysis of regulations,for improving China's drug clinical trials and change management during clinical trials,especially for the sponsor change or production site change,and their change management during clinical trials.Methods:The regulatory requirements and implementation of European Union(EU)drug clinical trial applications and change management during clinical trials were collected and studied.Suggestions were provided by comparing them with the present regulatory framework and situation of China.Results and Conclusion:In EU,the clinical trial sponsors and clinical trial drug production sites are allowed to apply for registration and change of clinical trials both domestically and internationally.The EU clinical trial regulatory system is relatively mature and complete which are of reference value to China,such as a unified clinical trial application portal website and clinical trial information database,an integrated system of scientific and ethical in parallel review procedures,the qualification and responsibility for the sponsors and their legally designated representatives,and measures of supervision and risk control for production sites of investigational drugs as well as their changes.
clinical trialchange managementsponsor changeproduction site changedrug administration
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