Already since 31 January 2023 all applications for new clinical ... Regulation). In addition, the sponsor should update trial documents to the CT Regulation by way of a substantial amendment Part ...
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EU’s Clinical Trials Regulation comes into full forcedubbed the Clinical Trials Regulation (CTR), puts an end to the three-year transition period under the Clinical Trials Directive (CTD). As part of the transition, the European Medicines Agency ...
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced sweeping changes to regulations governing clinical trials, which it says are the largest in more than 20 years.
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