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M4E(R2) - European Medicines Agency

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 ph

and interpretation of these findings together with any other relevant information (e.g., pertinent animal data or product quality issues that may have clinical implications). The Clinical Overview is primarily intended for use by regulatory agencies in the review of the clinical section of a marketing application.

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