Your Majesty,

Executive Director [Emer] Cooke,

Ladies and gentlemen,

I am honored to speak on behalf of Olivér Várhelyi, the European Commissioner for Health and Animal Welfare.

Today marks the 30th anniversary of the EMA, an agency that has upheld the highest standards for medicines in the EU.

Congratulations on reaching this significant milestone and all that has been achieved since the EMAs establishment.

I valued my visit to the EMA earlier this year and regret that I cannot be with you today due to other commitments.

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The world today is vastly different from the 1990s.

Science and regulations have evolved significantly, impacting your responsibilities.

Yet, your partnership with the European Commission remains strong.

In this first year of the new mandate, we rely on the EMA to help us achieve our ambitious goals.

The European Commission has outlined its vision for a European Health Union, focused on protecting citizens from health threats, ensuring access to innovative medicines, and supporting a robust pharmaceutical sector.

Since its inception in 1995, the EMA has been the foundation of medicine regulation in Europe.

Your rigorous assessments safeguard both human and animal health.

Beyond regulation, the EMA fosters innovation, collaboration, and prepares our healthcare systems for future challenges.

Your essential work ensures that medicines in the EU remain safe and effective.

The Agencys robust assessments form the basis for the Commissions decisions on medicine authorizations.

In 2024, you recommended over 100 new human medicines for approval, the highest in 15 years, alongside 23 new veterinary authorizations.

Your scientific advice accelerates the development of vital treatments.

Through initiatives like the Clinical Trials Information System, you facilitate interactions between trial sponsors and regulatory authorities, enhancing the development of new medicines.

Moreover, the EMA continuously monitors the safety and quality of medicines post-market, employing advanced technologies to swiftly address risks.

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Now, with an extended mandate, the EMA plays a critical role in crisis preparedness and managing medicine shortages.

You are pivotal in combating antimicrobial resistance and promoting responsible use of antibiotics.

Your monitoring of antimicrobial sales informs responsible usage in animals, supporting the One Health approach.

The EMAs efforts in veterinary medicine are crucial for both animal and human health.

As the Agency implements the Veterinary Medicines Regulation, your scientific advice shapes legislation that protects public health.

Beyond medicines, the EMA also influences medical devices, facilitating faster access to safer and more effective solutions.

Your expertise is vital for the interplay between devices and medicines.

These contributions are essential to the European Health Union.

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The EMAs role will continue to grow as the EU reforms its pharmaceutical legislation and develops a Critical Medicines Act.

These reforms aim to modernize regulations, ensuring access to affordable and innovative medicines while maintaining sector competitiveness.

Your involvement in monitoring supply chains is crucial for preventing shortages, as demonstrated by the launch of the European Shortages Monitoring Platform.

With a streamlined structure and enhanced digital tools, your efficiency can improve significantly.

As global competition in medicines intensifies, we must ensure Europe remains a hub for medical research and innovation.

The agility of our regulatory environment will determine the success of our pharmaceutical sector.

We anticipate that the reforms will lead to quicker procedures and improved efficiency.

We need to enhance our biotechnology landscape, as evidenced by the Draghi report highlighting Europes need for action in this sector.

The EMA will be central to developing a biotech-based European Health Industry, providing high-quality therapies globally.

We aim to adopt an ambitious Biotech Act to harness the potential of biotechnology in healthcare.

This should lead to earlier disease identification and revolutionary therapies for European patients.

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Ladies and gentlemen,

The EMA has become one of the EUs most respected agencies, employing nearly 1,000 people. Thank you to everyone who contributed to this achievement. Take the time to celebrate today.

I look forward to our continued collaboration.

Thank you!