DARWIN EU® – The European Medicines Agency’s Initiative for RWE Integration in Medicines Evaluation
The European Medicines Agency (EMA) began the process of establishing a Coordination Centre for Data Analysis and Real-World Integration Network (DARWIN EU®) on February 9, 2022. It’s the first step toward incorporating Real-World Evidence (RWE) into drug evaluation across the European Union (EU). Any Regulatory Agency’s primary responsibility is to ensure the safety and efficacy of medications, and RWE is proven to be a dependable source of real-time evidence from worldwide health-care databases. As a result, the EMA’s action aims to improve the quality of pharmaceuticals in the EU and make them more accessible.
Major Activities Planned for the Coordination Centre for DARWIN EU®
How will the DARWIN EU® assist the EMA and other relevant regulatory authorities?
The necessity of the hour is for innovative drugs to be widely available to patients. Regulatory processes for medication development, approval, marketing, and post-marketing surveillance take a long period, resulting in unfulfilled demand for new drugs. The way forward is to reduce time-to-market while assuring the safety, efficacy, and quality of novel pharmaceuticals. Several global health authorities are recognising the advantages of incorporating RWE into their regulatory approvals, and the EMA’s approach is DARWIN EU®.
Under this programme, the EMA intends to link the European Medicines Regulatory Network to the European Health Data Space (EHDS) for improved data exchange and access to various health data types. It will also provide guidelines for scientific assessments and regulatory decisions.
The DARWIN EU® intends to accomplish the following activities:
• Using RWE in decision-making for the regulation of new medications, vaccines, and other products.
• Integrating RWE throughout a drug’s lifetime, including development, approval, and post-market surveillance
• Be ready for future medical emergencies like pandemics.
• Provide valuable and accurate RWE on patients, diseases, and drug usage to the pharmaceutical sector.
• Make educated regulatory decisions based on RWE to ensure that medications are used safely and effectively.
• More life-saving medications are available to patients in need thanks to precise and rapid data analysis.
Timelines proposed for DARWIN EU® to become a fully operational network in the EU
The EMA further defines the following deadlines for DARWIN EU® to be fully operational:
• The project will begin in 2021.
• DARWIN EU® is established in 2022.
• 2023 – DARWIN EU® development and usage definition
• 2024 – Complete implementation of DARWIN EU®
• Enhance regulatory uses of health-care data by 2025.
expanding the scope in terms of medical, location, and other factors
The EMA is establishing DARWIN EU® in collaboration with Erasmus University Medical Center Rotterdam. The purpose of this collaboration is to develop a distributed data network by establishing a coordination centre. They’ve also taken on the responsibilities of conducting scientific studies, assisting regulatory decision-making, and maintaining a database of real-world data sources.
What Does DARWIN EUInitiation ®’s Mean for the Future?
In their five-year strategy documents, the EMA and the Heads of Medicines Agencies (HMA) have always worked collaboratively to identify issues, set time-bound goals, and define priorities. Its purpose is to provide strategic direction to the European Medicines Regulatory Network’s activities.
The launch of DARWIN EU® is a significant step forward in the EMA’s Network Strategy implementation. The major goals are to conduct scientific investigations to answer research questions, to promote the evaluation of medicines in the EU, and to maintain information for medication regulatory activities. DARWIN EU® is expected to be a major factor in European medication regulation, with pilot studies expected to be completed by the end of 2022.
Contact the Regulatory Affairs professionals at Freyr if you are a medication producer and want to learn more about RWE and how it is impacting the future of regulatory decision-making.
Category: Pharmaceuticals, Regulatory Affairs, Market Access
Key Words: Pharmaceuticals, Regulatory Affairs, Big Data, Scientific Reports, Innovator Drugs, EMA, EMA Implementation, Market Access
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