Transcription of M4E(R2) - Common technical document for the registration ...
{{id}} {{{paragraph}}}
Example: biology
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.
address particular efficacy or safety issues encountered in development, and how they have been evaluated and resolved. explore unresolved issues, explain why they should not be considered as barriers to approval, and describe plans to resolve them. explain the basis for important or unusual aspects of the prescribing information.
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: