The European Union is marking the 30th anniversary of its centralised system for approving medicines. This milestone highlights the role the EU has played in supporting public health, innovation, and the competitiveness of the pharmaceutical industry across its Member States.
Commissioner Várhelyi commented on the occasion: “Medicines are essential for strong health systems. This is why, thirty years ago, the European Union took a decisive step to strengthen public health, support innovation and reinforce the competitiveness of EU’s pharmaceutical industry by creating a centralised system for approving medicines. Ever since, this system – built on scientific excellence and rigorous safety standards – has been central to EU health policy, bringing patients and healthcare workers almost 2,000 medicines.”
The centralised authorisation process allows companies to obtain approval for new medicines through a single procedure that applies across all Member States. This approach aims to provide faster and more equitable access to treatments for various conditions such as cancer, cystic fibrosis, diabetes, hepatitis C, HIV, multiple sclerosis and rare diseases.
Commissioner Várhelyi also stated: “Under this process, companies can bring safe and innovative medicines to patients in all Member States through a single, streamlined authorisation system. Industry has enjoyed much needed predictability and efficiency, and European citizens have had faster and more equitable access to treatments for conditions such as cancer, cystic fibrosis, diabetes, hepatitis C, HIV, multiple sclerosis and several rare diseases.”
Europe’s pharmaceutical sector employs hundreds of thousands of people. The combination of high regulatory standards with an efficient approval pathway has contributed to making Europe a competitive location for research and development.
“Europe’s pharmaceutical sector is one of our most dynamic and innovative industries, employing hundreds of thousands of people. By combining high regulatory standards with a streamlined approval pathway, the centralised system has enhanced Europe’s competitiveness and made the EU an attractive location for research and development,” said Commissioner Várhelyi.
Looking forward, the European Commission intends to adapt its rules in response to global competition and advances in science. Priorities include reforms of pharmaceutical legislation as well as adopting acts related to critical medicines and biotechnology.
Commissioner Várhelyi added: “Looking ahead, we will continue building on this success. Global competition is intensifying, scientific advances are accelerating, and patients expect timely access to innovation. To ensure that Europe remains a pioneer we need to adapt our rules to keep pace with the digital transformation and new technologies and accelerate procedures. This is why ensuring that the reform of EU pharmaceutical legislation and the Critical Medicines Act are adopted as soon as possible and adopting a proposal for a Biotech Act are key priorities.”
He concluded: “As we mark 30 years of centralised EU medicines approval, we are more committed than ever to a strong, competitive, and innovative European pharmaceutical sector – one that brings the best treatment to patients more quickly, upholds the highest standards of safety and trust and drives economic growth. Our aim is to ensure, together, that Europe remains a leader in health innovation for the next generation.”
The first medicine approved under this system was authorised by the Commission on 20 October 1995. Since then approximately 2,000 medicines have undergone assessment through this process before being placed on the EU market.
For further details about the history of medicine approvals in Europe over the past three decades or about current legislative priorities regarding pharmaceuticals in the EU can be found at Factsheet – 30 years of EU medicine approval.
