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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)

The purpose of the 5th revision of the main guideline is to address current changes in the therapeutic landscape that affect the requirements with regard to collection and reporting of safety data in order to inform the benefit-risk evaluation, including a need for more differentiated and detailed safety data

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