Finding effective treatment for patients with rare diseases can be very difficult. Since the EU orphan regulations entered into force in 2000, it has played a central role in facilitating the development and authorisation of medicines for rare diseases.

In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the...

In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the...

In the last quarter of 2020, the European medicines agencies network - comprising national competent authorities (NCAs) and the European Medicines Agency (EMA) - published its five-year strategy covering the period from 2021 to 2025. The strategy (EMANS 2025) has now undergone an update to cover...

In the last quarter of 2020, the European medicines agencies network - comprising national competent authorities (NCAs) and the European Medicines Agency (EMA) - published its five-year strategy covering the period from 2021 to 2025. The strategy (EMANS 2025) has now undergone an update to cover...

Welcome to the 2024 EMA annual report, which highlights milestones and achievements of the past year, and our regulatory network's commitment to bringing value to public and animal health in the European Union (EU).

Welcome to the 2024 EMA annual report, which highlights milestones and achievements of the past year, and our regulatory network's commitment to bringing value to public and animal health in the European Union (EU).

Welcome to the 2024 EMA annual report, which highlights milestones and achievements of the past year, and our regulatory network's commitment to bringing value to public and animal health in the European Union (EU).