Transcription of Guideline on development, production, characterisation and ...
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Guideline on development, production, characterisation and ...
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. 21 July 2016 EMA/CHMP/BWP/532517/2008 Committee for medicinal products for human use (CHMP) Guideline on development, production, characterisation and specification for monoclonal antibodies and related products 3R s technical update January 2016 Agreed by Biologics Working Party January 2016 Adopted by CHMP July 2016 Date for coming into effect September 2016 * This is a technical update to reflect current best practice with regard to implementation of 3Rs approaches and it is not intended as a full revision
Agreed by Biologics Working Party ; January 2016 . Adopted by CHMP : July 2016 . Date for coming into effect : September 2016 * This is a technical update to reflect current best practice with regard to implementation of 3Rs
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