Posted on 07 May 2019

Regulatory News - May 2019

EMA published Q&As for patients, healthcare professionals and the general public on EU actions to prevent medicine shortages due to Brexit.

EMA has published a questions-and-answers (Q&A) document for patients, healthcare professionals and the general public on the preparatory work that European Union authorities are doing to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU. It explains that in case of a withdrawal agreement, there will be a transition period during which EU law will continue to apply in the United Kingdom. This means that access to medicines will not be affected. If the UK leaves without a withdrawal agreement or deal (‘no-deal scenario’), EU law will cease to apply in the UK. In this case, in order to be able to continue to supply medicines in the EU, companies carrying out certain activities in the UK will need to make changes to comply with EU law.

The Q&As explain how EMA, the European Commission and EU/EEA Member States have been working closely together since May 2017 to advise companies on how to apply for the necessary changes in order to minimise the impact on the supply of medicines, if the UK leaves the EU without a withdrawal agreement.

The document underlines that Brexit will not impact the safety of medicines, nor the way they are evaluated. EMA and the Member States will continue to monitor the safety and efficacy of medicines without any changes.

This document applies to both human and veterinary medicines and will be updated as necessary.

EMA Consultation: ICH guideline E19 on optimisation of safety data collection. 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. Comments should be provided using this template and sent to by 29 September 2019.