News

Regulatory Science to 2025

published 5 Dec 2019

Authors: Cristiana Suciu

On the 18th and 19th of November, the European Medicines Agency (EMA) hosted its multi-stakeholder workshop, with a focus on Regulatory Science to 2025.

The European Commission’s priorities continue to be the supply of affordable and sustainable medicines, ensuring patient access to innovative medicines and oversight of the global supply chain. Their focus on flexible legislation as well as the implementation of the clinical trial regulations and medical device legislation is hoped to simplify several processes in the regulatory sector. It is hoped these changes will foster innovation in the pharmaceutical industry, with emphasis on unmet medical needs and paediatric formulations. (1)

The EMA would also like to encourage communication between member states as a proactive way of advancing regulatory science.

The EMA’s 5 goals for Regulatory science 2025 are: (2)

Industries have welcomed the EMA’s focus on harmonising regulatory aspects throughout the EU, in the hope that this will eventually lead to global alignment for both Clinical trial applications but also Life cycle management of authorised medicines. Great consideration is being offered to medical devices, in vitro diagnostics and drug device combinations and their regulation. Industry stakeholders feel the need to obtain joint assessment and joint advice on development plans of devices, from both competent authorities and notified bodies. With an increased emergence of global medicines, there’s now pressure to harmonise the regulatory requirements for assessment across not just Europe but also with the FDA. In addition, a clear role for the notified bodies and competent authorities needs to be defined, with better communication between the two institutions, especially when resolving conflict in cases of misalignments has been identified. (3)

Overall, steps are being taken across a range of regulatory activities, to simplify processes and reduce administrative burden. It is hoped these steps will aid the EMA’s goal in supplying quality and innovative medicine to patients.

References:

  1. https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-welcome_en.pdf
  2. https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-overview-outcome-publication-consultation_en.pdf
  3. https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-create-integrated-evaluation-pathway-assessment-medical_en.pdf