Draft guideline on pharmaceutical development of medicines for paediatric use

Guideline on pharmaceutical development of medicines for paediatric use

Draft Agreed by QWP February 2011 Draft agreed by SWP March 2011 Draft agreed by PDCO April 2011 Adoption by CHMP for release for consultation May 2011 End of consultation (deadline for comments) 31 December 2011 Revised version agreed by QWP for release for second consultation September 2012 Revised version agreed by PDCO for release for second consultation November 2012 Revised version adopte...

Guideline on pharmaceutical development of medicines for paediatric use

Draft agreed by QWP February 2011 Draft agreed by SWP March 2011 Draft agreed by PDCO April 2011 Adoption by CHMP for release for consultation May 2011 End of consultation (deadline for comments) 31 December 2011 Revised version agreed by QWP for release for second consultation September 2012 Revised version agreed by PDCO for release for second consultation November 2012 Revised version adopte...

European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use

DRAFT AGREED BY BIOLOGICS WORKING PARTY 18 April 2007 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION 24 May 2007 END OF CONSULTATION (DEADLINE FOR COMMENTS) 30 November 2007 AGREED BY BIOLOGICS WORKING PARTY 12 November 2008 ADOPTION BY CHMP 18 December 2008 DATE FOR COMING INTO EFFECT 1 July 2009 This guideline replaces the guideline on “Production and quality control of monoclonal antibodies” ...

Draft reflection paper on the pharmaceutical development of medicines for use in the older population

Draft guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias