Transcription of Guideline on non-clinical and clinical development of ...
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Guideline on non-clinical and clinical development of ...
26 February 2015. EMEA/CHMP/BMWP/32775/2005_Rev. 1. Committee for medicinal products for Human Use (CHMP). Guideline on non- clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues Draft revision agreed by BMWP November 2012. Adopted by CHMP for release for consultation 13 December 2012. Start of public consultation 14 December 2012. End of consultation (deadline for comments) 30 June 2013. Draft revision agreed by BMWP April 2014. Adopted by CHMP for release for consultation 25 April 2014. Start of public consultation 30 April 2014. End of consultation (deadline for comments) 31 July 2014. Agreed by BMWP February 2015. Adopted by CHMP 26 February 2015. Date for coming into effect 01 September 2015. This Guideline replaces 'Guidance on similar medicinal products containing recombinant human soluble insulin' (EMEA/CHMP/BMWP/32775/2005). 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555.
Committee for Medicinal products for Human Use (CHMP) Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues . ... • Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98) ...
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