Transcription of E 8 General Considerations for Clinical Trials
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E 8 General Considerations for Clinical Trials
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 14 October 2021 EMA/CHMP/ICH/544570/1998 Committee for Human Medicinal Products ICH guideline E8 (R1) on General Considerations for Clinical studies Step 5 Transmission to CHMP 25 April 2019 Adoption by CHMP 25 April 2019 Release for public consultation 10 May 2019 Deadline for comments 30 September 2019 Final adoption by CHMP 14 October 2021 Date for coming into effect 14 April 2022 ICH guideline E8 (R1) on General Considerations for Clinical
The ICH document "General Considerations for Clinical Trials" is intended to: a) describe internationally accepted principles and practices in the conduct of both individual clinical trials and overall development strategy for new medicinal products. b) facilitate the evaluation and acceptance of foreign clinical trial data by promoting
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