As part of the EU Pharmaceuticals Strategy, and lessons learned from the COVID-19 pandemic, the European Commission (EC) declared its plans to assess and revise the EU’s general legislation on medicines for human use (Directive 1001/83/EC
and Regulation 776/2004) to safeguard a future-proof and crisis-resistant medicines regulatory system. EFPIA has participated actively in the dialogue with all relevant stakeholders from legislators/regulators to patients and healthcare professionals, not to mention the different types of medicine developers, preceding these official steps. We have constantly evolved our goals on how to enhance the legislative framework in the EU and at the same time looked at how we can make improvements already now to support today’s innovations and those for the future for the patient to reach them faster.
This is the Regulatory Road to Innovation (RRI) with the objectives to enhance the policy and regulatory environment in Europe to deliver safe, efficacious and high-quality treatments, vaccines and diagnostics to patients.
In order to highlight concretely on how the main priority goals of RRI could be reached, we partnered with industry topic leads to generate a blog publication for the EFPIA’s blog page called “EFPIA View’’. The purpose was to create reader-friendly, timely, interesting and sometimes thought-provoking articles.
This blog collection comprises all these topics published between April 2022 to March 2023 on the following topics:
1. EU Regulatory Network – New architecture for a new era
2. Complex Clinical Trials – A decade of innovation in clinical research: from a Drug centric to a Patient centric approach
3. Supply Chains reshaping – How to respond to a crisis
4. The future treatment of patients – Combination Products and Companion Diagnostics
5. Expedited Regulatory pathways – A toolbox to provide innovative medicines to patients
6. Electronic Product Information (ePI) – Making the latest medicine’s information available for patients without any delay
7. Digital endpoints for patient-focused health management
8. A sustainable environment for a healthy population1
9. Real-world data/evidence: How it can inform patient treatment and care decisions
10. How regulation can boost the EU innovation?2
11. Dynamic Regulatory Assessment will support more efficient treatment development for patients: the time to pilot is now
12. A modernized EU Variation Framework for enhancing the life of European patients