Information management has become an integral part of the European Medicines Agency's (EMA) mission to promote and protect public and animal health. This is driven by the increasing importance of interconnected information technology (IT) systems for managing and sharing information on medicines, the growing range of EMA's external users with different information requirements and the overall digital transformation of society and regulation.
The European medicines regulatory network relies on IT services to support all activities related to the authorisation and supervision of human and veterinary medicines in the European Union (EU). EMA makes available and maintains many of these IT services.
EMA staff and experts need IT solutions from EMA to carry out their core regulatory work. Many external stakeholders also increasingly rely on EMA's IT systems.
Pharmaceutical companies expect IT systems that help them meet their regulatory requirements more efficiently and cost-effectively.
Patients and healthcare professionals demand timely access to public information on medicines, so they can make their own decisions.
The globalisation of medicines means that EMA needs to share more information with regulatory authorities worldwide.
Academic sponsors rely on EMA's services, and the information EMA holds is also relevant for academic research.
EMA's Information Management strategy 2020-2022 is a high-level, business-oriented description of how EMA uses IT to achieve its mission and deliver its business objectives:
The strategy guides EMA’s IT investment and helps shape the operational framework for IT delivery.
The core activities it describes feed into EMA’s multiannual work programme, EU Telematics strategy and other EMA business strategies. It was first endorsed by the EMA Management Board in December 2017, then revised in December 2018 and December 2019 to take account of changes in EMA's operating environment and priorities, as part of EMA's annual planning cycle.
EMA’s IT investments fall into three main categories. In order of priority, these are:
- delivering external commitments (e.g. implementing new legal requirements);
- maintaining operational stability and continuing to deliver on existing commitments (e.g. maintaining and upgrading technology underpinning current regulatory processes);
- building EMA capabilities and thereby those of the European medicines regulatory network (e.g. investing in technology that enhances EMA's ability to deliver on its commitments).
In 2020, EMA is carrying out IT development work on the following programmes and projects:
- developing a Clinical Trials Information System to support the implementation of the Clinical Trial Regulation;
- delivering the EU Veterinary medicines legislation including an enhanced EudraVigilance Veterinary system and a Union Product Database;
- digitalising EMA's administrative processes;
- providing further releases of the IRIS platform;
- delivering the Substance, product, organisation and referential (SPOR) master data services;
- providing data analytics services;
- supporting EMA's information classification and implementation of the EU Data Protection Regulation (EUDPR).