Regulatory Road to Innovation
Delivering safer, better medicines to patients - faster than we've ever done before
The Regulatory Road to Innovation
At EFPIA we are working to discover and develop innovative therapies, to deliver people the treatments they need, and eventually ensure a healthier future for European patients. Developing new medicines is a long, complex and risky process with no guarantee of success. It begins with the spark of an idea.
The regulatory framework is the process that allows to take this idea for a new treatment through clinical trials and tests to ensure it’s safe and effective, all the way through the final authorisation, before it can be made available to patients.
The European regulatory system has done great so far. For instance:
This revision is a chance to create an agile and streamlined regulatory framework, making Europe more competitive and bringing breakthroughs to patients faster.
Throughout the medicine's life cycle, we have identified 8 areas for immediate action and 4 areas requiring legislative change to accelerate pharmaceutical innovation in Europe:
Why Europe must future-proof its pharma legislation
Listen to our podcasts
At EFPIA we are working to discover and develop innovative therapies, to deliver people the treatments they need, and eventually ensure a healthier future for European patients. Developing new medicines is a long, complex and risky process with no guarantee of success. It begins with the spark of an idea.
The regulatory framework is the process that allows to take this idea for a new treatment through clinical trials and tests to ensure it’s safe and effective, all the way through the final authorisation, before it can be made available to patients.
The European regulatory system has done great so far. For instance:
- It served patients: Since its foundation in 1995, the European Medicines Agency has recommended the authorisation of over 1,500 new medicines[1].
- It supported investments: It has helped to attract the €41.5 billion that the pharmaceutical industry invests in European research and development every year[2]. Investments are needed to ensure continuous innovation of new treatments.
This revision is a chance to create an agile and streamlined regulatory framework, making Europe more competitive and bringing breakthroughs to patients faster.
Throughout the medicine's life cycle, we have identified 8 areas for immediate action and 4 areas requiring legislative change to accelerate pharmaceutical innovation in Europe:
Why Europe must future-proof its pharma legislation
Listen to our podcasts
Regulatory Road to Innovation Experts' Insights
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A modernised EU Variation Framework for enhancing the life of European patients
Regulatory Road to Innovation16.03.23Read Article -
Dynamic Regulatory Assessment will support more efficient treatment development for patients: the time to pilot is now (Guest Blog)
Regulatory Road to Innovation02.03.23Read Article -
How Regulation Can Boost the EU Innovation?
Technology moves fast. An agile and streamlined innovation ecosystem would make Europe more competitive and bring breakthroughs to patients.23.02.23Read Article -
Real-world data/evidence: How it can inform patient treatment and care decisions (Guest Blog)
Regulatory Road to Innovation09.02.23Read Article -
A sustainable environment for a healthy population (Guest Blog)
There is strong agreement between Bengt Mattson and Andreas Haener, chairs of the Interassociation Industry Pharmaceuticals in the Environment Task Force (IAI PiE TF) – industry has taken big steps over the past decade to combat the impact of pharmaceuticals in the environment.23.01.23Read Article -
Digital endpoints for patient-focused health management
Besides providing more precise and accurate assessments, digital endpoints could significantly decrease the time and costs related to trial participation, predominantly for persons with physical or time limitations.30.11.22Read Article -
Electronic Product Information (ePI) – Making the latest medicine’s information available for patients without any delay
Increasing access to medicines information and to the most updated regulator-approved information.02.11.22Read Article -
Expedited regulatory pathways: A toolbox to provide innovative medicines to patients
For Europe to stand its ground amongst other international regulatory authorities, it is crucial to evolve and future-proof EU expedited regulatory pathways.05.10.22Read Article -
The future treatment of patients - Combination Products and Companion Diagnostics (Guest blog)
Regulatory Road to Innovation14.09.22Read Article -
Supply Chains reshaping - How to respond to a crisis
#RegulatoryRoadtoInnovation23.06.22Read Article -
Complex Clinical Trials – A decade of innovation in clinical research
From a Drug centric to a Patient centric approach19.05.22Read Article -
EU Regulatory Network - New Architecture for a New Era (Guest blog)
Imagine you built a house. It was not big, but sufficient for what you needed at the time. Over the years, your family grew, and that same house was not sufficient anymore. You realize you need to renovate so that it fits your current and future needs.28.04.22Read Article
[1] European Commission, Union Register of medicinal products for human use.
[2] EFPIA, The Pharmaceutical Industry in Figures, 2019