Transcription of M4E(R2) - Common technical document for the registration ...
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M4E(R2) - Common technical document for the registration ...
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 15 July 2016 EMA/CPMP/ICH/2887/1999 Committee for Human Medicinal Products M4E(R2) - Common technical document for the registration of pharmaceuticals for human use Efficacy Step 5 Transmission to CHMP August 2015 Adopted by CHMP for release for consultation 24 September 2015 Start of public consultation 7 October 2015 End of consultation (deadline for comments) 31 December 2015 Final adoption by CHMP 21 July 2016 Date for coming into effect 31 January 2017 M4E(R2) - Common technical document for the registration of pharmaceuticals for human use Efficacy EMA/CPMP/ICH/2887/1999 Page 2/53 M4E(R1) document History First Codification History Date New Codification November 2005 M4E Approval by the Steering Committee under Step 2 and release for public consultation.
assess the quality of the design and performance of the studies, and include a statement regarding GCP compliance. provide a brief overview of the clinical findings, including important limitations (e.g., lack of comparisons with an especially relevant active comparator, or absence of information on some
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