Non-clinical Working Party documents

The Non-clinical Working Party (NcWP) publishes documents related to its work on this page. Some document titles mention the retired Safety Working Party (SWP), as the NcWP has taken over the tasks of the SWP in 2022.

Report on divergent opinion between EFSA and EMA on bisphenol-A

AdoptedReference Number: EMA/150385/2023

CHMP SWP opinion on diethanolamine and coconut oil diethanolamine condensate as excipients

Reference Number: EMA/275956/2021

CHMP Safety Working Party’s response to CMDh questions on chlorobutanol

AdoptedReference Number: EMA/CHMP/SWP/482438/2020 Corr.1

Safety Working Party (SWP) / Non-clinical Working Party (NcWP) recommendations on the duration of contraception following the end of treatment with a genotoxic drug

Reference Number: EMA/CHMP/SWP/74077/2020 Rev. 1

CHMP Safety Working Party’s response to the PDCO regarding aluminium hydroxide contained in allergen products

AdoptedReference Number: EMA/CHMP/381064/2010

Guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors

AdoptedLegal effective date: 01/05/2007Reference Number: EMEA/273974/2005

Overview of comments received on a draft guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors(EMEA/273974/2005)

Reference Number: EMEA/360592/2006

CHMP SWP Reflection Paper on PPARs (Peroxisome Proliferator Activated Receptors)

Reference Number: EMEA/341972/2006

CHMP SWP reflection paper on the assessment of the genotoxic potential of antisense oligodeoxynucleotides

AdoptedReference Number: EMEA/CHMP/SWP/199726/2004

CHMP SWP conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment - Revision 1

AdoptedReference Number: CPMP/SWP/2592/02 Rev 1