EMA-raadpleging: ICH-richtlijn E19 over optimalisatie van veiligheidsgegevensverzameling

The European Medicines Agency has released for public consultation the ICH guideline E19 on optimisation of safety data collection (step 2b).

This guideline explores under what circumstances a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies would be appropriate and how to implement such an approach. This approach could reduce the burden to patients which can serve as a disincentive to participation in clinical research, while recognising that protection of patient welfare during medicine development is of critical importance. The aim is to enable a larger number of informative clinical studies to be carried out with greater efficiency and greater global participation in studies, for the benefit of public health.

The draft guideline is available by clicking here.

Comments should be provided using this template and sent to ich@ema.europa.eu by 29 September 2019.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).