Your Majesty,

Executive Director [Emer] Cooke,

Ladies and gentlemen,

[I am pleased to deliver you the speech on behalf of Olivér Várhelyi, the European Commissioner for Health and Animal Welfare —SANTE Director-General, Sandra Gallina]

Today, we celebrate 30 years of excellence.

For 30 years, the European Medicines Agency has made sure that medicines in the EU meet the highest standards.

That they are safe, effective and high quality.

Let me sincerely congratulate you on this important  anniversary and what you have accomplished since EMA was established three decades ago.

I highly appreciated my visit to the EMA in February this year and the chance to talk with the staff. I regret not being able to join you today. This is due to the exceptional situation in the Netherlands related to another high-level event as well as to short-notice imperative tasks related to a College meeting.

***

Compared to the 1990s, the world is a very different place today.

Both science and our regulations have significantly evolved in the decades since then – which has impacted your work and your responsibilities.

But what has remained consistent is that you continue to be a close partner to the European Commission.

We are still in the first year of this mandate for the European Commission.

And we are counting on the EMA to continue helping us meet our ambitious goals.

The European Commission outlined its vision for a European Health Union.

A European Health Union that protects its citizens from health threats.

That ensures access to innovative and affordable medicines.

That supports a competitive and robust pharmaceutical and medical device sector as well as biotechnology in the EU.

Since its inception in 1995, the EMA has served as the bedrock of medicine regulation in Europe.

You have worked tirelessly to protect human health and animal health through rigorous scientific assessment and supervision.

But the EMA is now far more than just a regulatory body.

You also drive innovation, foster collaboration, and ensure that our healthcare systems are equipped to face the challenges of today and tomorrow.

Of course, the EMAs main contribution remains ensuring medicines in the EU are safe, effective, and high quality.

The sound and robust assessments by the Agency and its Scientific Committees are the basis for Commission decisions to centrally authorise medicines in the EU.

You are instrumental in getting new, innovative medicines to patients across the EU, more quickly.

And you are stepping up this work.

In 2024, you recommended over 100 new human medicines for approval – the highest number in 15 years.

That same year, the Commission also adopted 23 new veterinary marketing authorisations, based on the EMAs recommendations.

At the same time, your scientific advice to medicine developers helps speed up the development of vital new treatments.

Through initiatives like this, the EMA also helps improve the environment for conducting clinical trials in the EU.

Together with the Member States and the Commission, the EMA maintains the Clinical Trials Information System and the public website. This application is crucial to support interactions between clinical trial sponsors and regulatory authorities.

This supports the development of new medicines and new treatments in healthcare.

Equally important is the EMA ensuring that our medicines remain safe and high quality once they are on the market.

This means using state-of-the-art technologies to quickly identify and address any risks.

Oversight mechanisms constantly monitor medicines for side effects throughout their whole lifecycle.

If new safety concerns emerge, then product information can be quickly updated – or stronger measures taken.

The EMA coordination of inspections of manufacturing sites ensures that companies adhere to strict good manufacturing practices.

This guarantees consistent quality in production.

This is the very foundation for patients to trust in their healthcare.

Now – under its extended mandate – the Agency also plays a vital role in addressing current and future health challenges.

This starts with a stronger role in crisis preparedness and managing shortages of medicines and medical devices.

The EMA is also an important part of the fight against antimicrobial resistance.

Promoting responsible antibiotic use and fostering new treatments is vital.

Your ongoing support in monitoring trends of sales and use of antimicrobials throughout the European Union is crucial.

It can help inform how best to support the responsible use of antimicrobials in animals.

This underlines the EMA role in the One Health approach, which emphasises the interconnectedness of human health and animal health – as well as plant health and the environment.

And so the EMAs work on the safety and quality of veterinary medicines is vital not only for animal health, but also for human health.

The EMA has played a key role in implementing the Veterinary Medicines Regulation.

The scientific advice provided by the EMA has been pivotal in shaping science-based legal measures that supplement the legislation. Be it banning the use of antimicrobials for growth promotion or preserving some of our most precious antimicrobials for humans.

Beyond medicines, the EMA also plays a role in medical devices.

Advice given by EMA medical device expert panels helps foster innovation and promote faster patient access to safer and more effective devices.

This is particularly important for the development strategy of high-risk medical devices.

We also count on your expertise for the interplay between medical devices and medicines, where your scientific advice on medical devices used together with medicines is crucial.

The contribution of the EMA in all these areas is vital to the European Health Union.

And these are just some of EMAs responsibilities.

***

Now the EMAs role is set to evolve and expand again.

As the EU reforms our pharmaceutical legislation and works towards a Critical Medicines Act.

The pharmaceutical reform is urgently needed, to modernise our rules and to ensure that patients can access affordable and innovative medicines across the EU and that the pharmaceutical sector remains competitive.

The EMAs contribution will be essential to making the pharmaceutical reform and the Critical Medicines Act a success.

You will actively work to prevent medicine shortages by monitoring supply chains. The timely launch of the European Shortages Monitoring Platform in February showed that we can count on your contribution.

You will also manage the list of critical medicines.

You will be involved in developing guidelines and putting into practice many of the measures envisaged in the pharmaceutical reform.

With a streamlined structure and simplified procedures, embracing digitalisation and AI to make better use of data, I am certain that your work can become even more efficient.

Global competition in the field of medicines keeps intensifying. We see emerging competitors in pharma innovation and the recently changed geopolitical environment makes raise stakes higher.

Will Europe remain a hub for medical research? Will our companies be able to innovate and manufacture in Europe? Will European patients have timely access to new therapies?

It all depends on how agile our regulatory and institutional environment is.

In this context, comparison of regulatory authorities by the stakeholders is inevitably happening. And here we see room for improvement.

We do hope that the pharma reform, with the shortened assessment deadlines and the streamlined governance structure, will bring quicker procedures.

Simply, we cannot continue with one-hundred-day longer median assessment timelines in comparison with the US Food and Drug Administration [FDA]. 

However, we need to see where we can gain further efficiency and in this I rely on your support and ideas.

In the same vein, we also count on your support in the field of biotechnology.

The Draghi report brings evidence that while advanced therapy medicinal products have the greatest potential of therapeutic breakthrough and economic grow in the sector, Europe is losing ground to US and China.

This calls for immediate action.

We need to have more streamlined and shorter procedures, closer dialogue with the stakeholders.

EMA will play a central role to build a new, increasingly biotech based European Health Industry where high quality, safe and efficient therapies are developed in Europe to the whole World.

The Commission intends to adopt an ambitious Biotech Act to make the most of the biotech revolution.

Biotech holds huge potential to help us achieve our goals, particularly in healthcare.

It means earlier and better disease identification, better prevention strategies and more personalised medicine and should mean new revolutionary therapies reaching European patients much earlier.

***

Ladies and gentlemen,

By now, EMA has grown into one of the EUs most successful and well-respected agencies, employing nearly 1,000 people. Once again, let me thank and congratulate all who have worked towards this achievement. Take your time today to celebrate.

I look forward to keeping our good work together going.

Thank you!