Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)

Description: Session 1: Introduction and Overview of the changes proposed in the Revision

The EU Commission is undertaking a review of the European pharmaceutical legislation; this is the first full-scale review for over 20 years and could have significant impacts to the future work of regulatory professionals in the biopharmaceutical sector. Although the EU regulatory system today is effective at bringing high quality, safe and efficacious products to the market, it is no longer efficient. Additionally, because the regulatory system is severely lacking the resources and capabilities that it needs, it is on the precipice of no longer being effective. This means we are facing an ineffective, inefficient regulatory system in the future. This session will discuss the strategic changes proposed in the revision of the Pharmaceutical legislation and explore the opportunities and challenges it seeks to address in Europe.
While the initial focus of the European Commission has been directed to addressing access and affordability concerns this session will also examine if the proposed changes also create opportunities to ensure Europe can remain at the forefront of medicines development and a hub for innovation in the future. Legislative frameworks must not become a barrier to harnessing innovation. The session will discuss if proposed changes effectively future-proof medicines regulation in Europe for the next 20 years, unlocking both current and future innovative technologies and medicinal products for the benefit of European patients.