EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals

Br J Clin Pharmacol. 2023 Aug;89(8):2341-2348. doi: 10.1111/bcp.15790. Epub 2023 Jun 2.

Jan Willem van der Laan^{1

2

3}, Mikael Andersson⁴, Sonja Beken⁵, Milton Bonelli⁶, Susanne Brendler-Schwaab⁷, Rosemary Kane⁸, Markku Pasanen^{2

9}, Stefano Ponzano⁶, Jakob Paur¹⁰, Christine Siezen¹, Anne Soleng¹¹, Rhys Whomsley⁶

¹ Medicines Evaluation Board, Utrecht, The Netherlands.
² ICH S1 Expert Working Group, European Medicines Agency, Amsterdam, The Netherlands.
³ Division of Drug Discovery and Safety, Leiden Academic Centre for Drug Research, University of Leiden, Leiden, Netherlands.
⁴ Medical Products Agency, Uppsala, Sweden.
⁵ Federal Agency for Medicines and Health Products, Brussels, Belgium.
⁶ European Medicines Agency, Amsterdam, The Netherlands.
⁷ Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.
⁸ Health Products Regulatory Authority, Dublin, Ireland.
⁹ School of Pharmacy, University of Eastern Finland, Kuopio, Finland.
¹⁰ Austrian Medicines and Medical Devices Agency (AGES), Vienna, Austria.
¹¹ Norwegian Medicines Agency, Oslo, Norway.

No abstract available

Keywords: 3Rs; ICHS1; carcinogenicity; human pharmaceuticals; regulatory assessment; weight of evidence.

MeSH terms