Genotoxic medicines and contraception: recommendations for all genotoxic active substances, regardless of therapeutic indication

date: 23/03/2022

The European Medicines Agency's Safety Working Party clarifies its recommendations on genotoxic medicines and the duration of contraception to apply to any genotoxic active substance, regardless of its therapeutic indication. However, the recommendations should not apply to active substances whose mechanism of genotoxicity is known to have a threshold which is not expected to be reached in patients. Marketing authorisation holders should take these new clarifications into account when considering the need to update their package leaflets.

The Safety Working Party (SWP) of the European Medicines Agency (EMA) provides recommendations on all matters relating directly or indirectly to non-clinical aspects of safety of medicinal products for human use. The SWP has revised the recommendations on genotoxic medicinal products and duration of contraception following a request for clarification from the Coordination Group for Mutual Recognition and Decentralised Procedures, Human (CMDh). The SWP has decided that the recommendations on genotoxic medicinal products and the duration of contraception should apply to any genotoxic active substance, regardless of its therapeutic indication. However, these recommendations should not apply to active substances whose mechanism of genotoxicity is known to have a threshold which is not expected to be reached in patients.

Marketing authorisation holders should take these revised recommendations into account when considering the need to update their package leaflets. The CMDh has now agreed that an assessment is required in cases where a calculation of contraceptive duration is submitted. These cases should therefore also be submitted as type II variations. If the calculation is taken from another product and no recalculation is required, a type IB variation is enough.

More information
•    CMDh communications on the subject: April 2021 (page 3) and July 2021 (page 1) 
•    FAMHP communication of 7 July 2021
•    The published SWP recommendation will be updated soon
 

Last updated on 23/03/2022