A jam-packed September: updates from EMSP’s meeting with the European Medicines Agency

18.10.2017 Logo of European Medicines Agency

EMA’s support to Multiple Sclerosis Registry initiative

After almost a year and a half of collaboration and consultations and following-up with a workshop held in July 2017, EMSP is proud to announce that the European Medicine’s Agency has recently published the report on Multiple Sclerosis Registries.

The EMA’s initiative for patient registries explores ways of expanding the use of patient registries in the benefit-risk evaluation of medicines within the European Economic Area. The mapping of existing MS registries across Europe showed that the differences between existing registries are wide. From their organisations, purposes to the core data collected and platforms used, the differences do not allow an efficient collaboration between registries that could optimise and facilitate the use of existing patients’ registries in the risk-benefit assessment of medicinal products on a long-term.

The workshop was meant to agree on recommendations on core data elements to be collected by MS registries, common procedures, consents, governance, data quality and registry interoperability as well as on actions to be undertaken for the development and implementation of those recommendations.

The EMA’s Patient Registry Task Force will work with MS stakeholders to take this initiative a step further and assist the registry holders towards a more harmonised and collaborative approach.

EMSP together with the support of the MS registries holders and the EMA has reached an important milestone towards the development of a harmonised data pooling system and the use of real world evidence data to support better decision making to improve the quality of life of the people living with MS.


On 20 – 21 September the EMA Human Scientific Committees’ Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting took place. Christoph Thalheim, External Affairs Director EMSP, also discussed the Patients’ registries initiative during this meeting. Stay tuned for the presentations and meeting report which will be available soon!

EMA hosted first public hearing on 26 September
Patients, carers, doctors, pharmacists and academia shared their experience with Valproate – a medicine that treats epilepsy, bipolar disorder and migraine at the first public hearing held by the European Medicines Agency (EMA) at its offices in London on 26 September 2017. For more details, please follow this link.

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