The long-awaited ICH M12 harmonised guideline on drug interaction studies was adopted on 21st May 2024. It is just a matter of time before it is implemented by the main regulatory agencies – in fact, the European Medicines Agency has already reached Step 5 of the process and announced that the guideline will come into effect on 30th November 2024. Therefore, it is essential companies are prepared for the change and know how the ICH M12 guideline differs from earlier guidance/guidelines so data can be collected and analysed correctly according to the new recommendations.
Cyprotex has produced some easy-to-follow flyers which highlight the key differences between existing guidance/guidelines from the US FDA, European Medicines Agency (EMA) and Japanese PMDA and the new harmonised ICH M12 guideline. These will help you get started on the transition process.
European Medicines Agency (EMA) vs ICH M12 Flyer
Japanese PMDA vs ICH M12 Flyer
Cyprotex is a centre of excellence for drug-drug interaction (DDI) studies. Our highly experienced team provide consultancy and guidance, and support you with the design, implementation and interpretation of in vitro DDI studies according to the regulatory guidance/guidelines, including the new ICH M12 guideline.
Discuss your project with us: