EMA SME Information Day

EUDRAC attended the SME Information Day "Regulatory Toolbox for Medicines and Combined Devices Developers" held at the offices of the European Medicines Agency (EMA) in Canary Wharf, London on 26th October 2018. SME Information Days provide an update on regulatory affairs topics for companies registered with SME status at EMA.

The Information Day included interactive seminars covering a wide variety of topics, such as:

  • a review of EMA experience with Conditional Marketing Authorisations (CMAs),
  • an update on recent developments with Advanced Therapy Medicinal Products (ATMP) guidance,
  • an overview of the implementation by EMA of the new Medical Devices Regulation,
  • an update on the Agency’s operational planning in preparation for Brexit.

Brexit

The Brexit update also featured a question and answer session with representatives from different functional areas within EMA and there was also the opportunity to meet with EMA staff during meeting breaks as part of the “Meet EMA” initiative.

Your Company

If your company meets the criteria of an SME, but are not yet established in the EU/EEA, you can still access SME incentives through an EU/EEA-established SME regulatory consultancy such as EUDRAC. Both the regulatory consultancy and the non-EU/EEA-based company have to be assigned SME status by the EMA SME office. SME benefits and incentives include fee reduction or deferral for a variety of pre- and post-approval procedures, together with additional direct procedural assistance, such as the provision of translation services following granting of an EU Marketing Authorisation.

More Information

Please click the links below for the presentations of the event and detailed report on the presentations from each speaker:

https://www.ema.europa.eu/en/events/info-day-micro-small-medium-sized-enterprises-smes-regulatory-toolbox-medicines-combined-devices