Information management is a critical enabler 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 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 technology capability investment plan aims to help the Agency develop into a customer-focused digital hub that provides high quality data and information services to the European medicines regulatory network.
The plan covers the following areas:
- Need to accelerate digital business transformation and enable an agile operating model
- Increasing business demand and upcoming legislative requirements
- Ageing technology landscape
- Tailored and fragmented databases that become increasingly costly to manage
- Need to increase productivity through automation and data integration
- Business opportunities created by new technologies
It aims to put in place technology and delivery methods that can support the implementation of key strategic priorities of the network by 2025. These include:
- EMA regulatory science strategy
- European Medicines Agencies Network strategy
- European medicines regulatory network data standardisation strategy
The plan builds on EMA's IT cloud strategy.
EMA published the plan in July 2022.
The Network Portfolio is the collective term for all EMA IT systems and services either being developed or already in operational use by partners and stakeholders, including EMA staff.
Investments in the portfolio facilitate EMA's mission of promoting and protecting public and animal health in the EU.
The portfolio includes both internal EMA systems and those used by external partners and stakeholders.
In this context, the cloud refers to a model which enables easy, on-demand access to a shared pool of customisable computing resources that can be supplied and released rapidly and with minimal effort.
Moving to the cloud enables EMA to transform its business processes and way of working.
For instance, cloud technologies make it easier for the Agency to meet its needs for secure and regulated exchange of data at European and global level.
With this strategy, EMA aims to:
- accelerate its digitalisation and innovation initiatives;
- accelerate adoption of the European Commission's European Health Data Space, an initiative to promote better exchange and access to different types of health data;
- increase return on its IT investments;
- maximise the quality of EMA's services offered to EU citizens and companies.
The strategy supports the European medicines agencies network strategy to 2025 and EMA's annual work programme.
It builds on EMA’s 2017 strategy to use public cloud solutions to support the Agency in achieving its mission.
For more information, see:
EMA is phasing in an Agile way of working and governance model for IT systems and services.
EMA set up new governance bodies in autumn 2021 and is piloting the Agile methodology in some of its IT projects.
In 2022 and 2023, EMA aims to move the complete Network portfolio to the new ways of Agile working.