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.
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 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.
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.
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.
Background
20 October marks the 30th anniversary of the first medicine approved by the Commission through the centralised EU authorisation procedure. Over the past three decades, around 2,000 medicines have been approved for the EU market, following a rigorous, science-based assessment process.
