Future Trends On European Regulations On Medicines

In November 2020, the European Commission announced the adoption of the new Pharmaceutical Strategy for Europe. The approach intends to ensure robust and fair competition and green industry, fostering patient access to innovative and affordable medicines. It also aims to ensure an autonomous and robust supply chain and a stronger EU voice at the global level by promoting a high level of quality, efficacy, and safety standards.

The Pharmaceutical Strategy is based on four main pillars:

• Accessibility and affordability of medicines for patients and addressing unmet medical needs
• Competitiveness, innovation, and sustainability
• Diversified and secure supply chain
• Ensuring a strong EU voice in the world

As part of the Pharmaceutical Strategy for Europe, the Orphan Regulation 141/2000 and the Pediatric Regulation 1901/2006 are under revision. The European Commission adoption was expected to occur by the fourth quarter of 2022.

In a recent webinar, regulatory experts examined and discussed the new medicinal products regulatory framework in Europe. Featured speakers included:

• Xavier Luria, MD, Vice President, Regulatory Affairs Europe, Veristat
• Michael Paul, Associate Director, European Regulatory Affairs, Veristat
• Paula Meler, Associate Manager, European Regulatory Affairs, Veristat 

Access the full webinar below to gain insight from the presentation with regards to unmet medical needs, accessibility and affordability, competitive and innovative European pharma industry, enhancing resilience, and the EU’s global voice.