Fellowship programmes involve exchanging staff for a short period of time. They enable the European Medicines Agency (EMA) and non-European Union (EU) regulators to exchange best practices, enhance mutual understanding and work together more closely.
The objective of fellowship programmes are to:
- enhance understanding of each other's structures, processes, practices and strategies;
- work closely together in priority areas and explore new areas of collaboration;
- exchange best practices in regulatory science and procedures.
The agencies plan and mutually agree on the structure of these visits, which could last for 2-3 weeks.
Fellowships with the United States
EMA and the United States Food and Drug Administration (FDA) have been running fellowships since 2009. Key achievements of these exchanges include:
- a better understanding of each other's practices,
- increased dialogue in various therapeutic areas, types of medicines, medicine development, evaluation and the safety monitoring of medicines;
- moving forward the EU/FDA mutual reliance initiative on good manufacturing practice inspections and the subsequent mutual recognition agreement signed in 2017.
They also enabled the agencies to establish new areas of cooperation, including:
- the creation of the patient engagement cluster. For more information, see Cluster activities;
- setting up quarterly exchanges on PRIME and the FDA's Breakthrough Therapy designations.
Fellowships with Japan
EMA and the Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) have agreed to establish a fellowship programme in 2017 on the model of EMA's fellowships with the FDA.
The first three-week EMA visit to the PMDA under the programme takes place in October 2017. It focuses on procedural aspects of the marketing authorisations, from pre-authorisation to the post-authorsiation stages. It aims to:
- identify practical ideas that EMA could integrate in its processes, taking into account the European medicines regulatory framework;
- explore opportunities to enhance cooperation, ideally by reducing duplication of work common to both agencies;
- deepen effective collaborations in strategic areas;
- promote regulatory science;
- improve understanding of the work and decisions taken by each agency;
- identify opportunities for further information sharing.
For more information, see: