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Guideline on the evaluation of anticancer medicinal ...

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, 2017 . Reproduction is authorised provided the source is acknowledged. 22 September 2017 EMA/CHMP/205/95 Committee for medicinal Products for Human Use (CHMP) Guideline on the evaluation of anticancer medicinal products in man Draft agreed by Oncology Working Party November 2015 Adopted by CHMP for release for consultation 25 February 2016 Start of public consultation 15 March 2016 End of consultation (deadline for comments) 15 September 2016 Adopted by Oncology Working Party April 2017 Adopted by CHMP 22 September 2017 Date of coming into effect 01 April 2018 This Guideline replaces Guideline on the evaluation of anticancer medicinal products in man' EMA/CHMP/205/95 Rev 4 Keywords Cancer, malignancy, biomarker, targeted drugs, pharmacogenomics Guideline on the evaluation of anticancer medicinal products in man EMA/CHMP/205/95 Page 2/43 Guideline on the evaluation of anticancer medicinal products in man Table of contents Executi ve summary.

22 September 2017 . EMA/CHMP/205/95 Rev.5 . Committee for Medicinal Products for Human Use (CHMP) Guideline on the evaluation of anticancer medicinal products in man . Draft agreed by Oncology Working Party . November 2015 : Adopted by CHMP for release for consultation : 25 February 2016 .

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  Product, 2017, Medicinal, Anticancer, Anticancer medicinal products

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