Network Portfolio

The Network Portfolio is the collective term for information technology (IT) systems and services managed by the European Medicines Agency (EMA). These may be under development or in production and use by EMA's partners, stakeholders and staff.  

The Network Portfolio facilitates EMA's mission of promoting and protecting public and animal health in the EU, and includes both internal EMA systems and those used by external partners and stakeholders.

EMA is responsible for developing and maintaining IT systems that enable the implementation of European pharmaceutical policy and legislation.

These services should be cost-effective, efficient and interoperable, helping to optimise support to the European medicines regulatory network in regulating medicines for the protection of human and animal health.

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.

Information on IT plans for the forthcoming period is available below in EMA's overall programming document (see Annex XIV).

EMA works with its partners in the European medicines regulatory network to develop and maintain IT systems.

EMA contacts any partners or stakeholders affected by its plans to ensure the successful adoption of new technology. 

EMA is phasing in an Agile way of working and governance model for IT systems and services, to better meet the needs of the European medicines regulatory network. 

EMA's Management Board endorsed the Agile transformation in June 2021, following a review of EMA's previous governance and delivery model for its IT portfolio. It is a multi-annual process due to conclude towards the end of 2023. 

The Agile transformation covers both the development of new IT systems and the maintenance of IT systems in production.

EMA is implementing Agile principles and the Scaled Agile Framework (SAFe) approach for its governance and decision-making processes.

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.

EMA’s Agile ambition is to shift from the previous model of rigidity to an agile approach of adaptability, to achieve the following benefits:  

• Greater transparency on how decisions are made and their outcomes 
• Clear ownership of decision-making 
• Improved business and IT alignment 
• Highly-focused portfolio-management practices 
• Better communication within the European medicines regulatory network and with industry 
• Greater focus on value

The Agile Transformation is supported by EMA's CIO Office and Portfolio Office. More information on EMA structures is available in Who we are. 

EMA has put in place a bespoke Agile governance model to ensure balanced and effective representation of EMA’s key partners and stakeholders. It contains the main components below: 

• EMA’s Portfolio Board is the main prioritisation body; it owns the Network Portfolio roadmap and backlog
• The Network Portfolio Advisory Group (NPAG) represents the Management Board and Heads of Medicines Agencies (HMA) within IT portfolio management; specifically, it attends relevant ceremonies jointly with the Portfolio Board, ensures oversight of progress and provides input on strategic decisions
• EMA's Architecture Board (EAB) formulates the longer-term IT vision and policy, and provides the architecture framework for development of new technology by the development teams in the value streams; It ensures data architecture standards are maintained, and reviews and endorses architecture and technology proposals
• The Network ICT Advisory Committee (NICTAC) provides insight on technical issues and technology and interoperability considerations of the regulatory network; it represents the national competent authority IT directors and experts community and European Commission

Governance bodies actively participate in regular ceremonies, which define the Agile way of working.

More details on the Agile portfolio governance structure are available in the documents below. 

In the Agile way of working, reporting and planning takes place in ceremonies, meeting at a regular cadence.

Each ceremony performs a specific function, and the participants are tailored to ensure the right representation and Agile implementation.

Value streams are a series of steps that help organisations to develop and deliver products, services or systems to costumers, in line with the Scaled Agile Framework (SAFe). 

A value stream should:

• reflect the main goals and values of an organisation;
• help create sub-portfolios that are independent and can support long-term strategic goals;
• be stable and long-lived, with a fixed budget, leadership, resources, and capacity.

EMA has implemented five value streams, each one focused on a set of capabilities:

• Research and development (R&D) - to foster R&D and generate scientific evidence.
• Product lifecycle management - to authorise and manage the lifecycle of medicines and medical devices.
• Monitoring - to monitor the availability and safety of products.
• Managing the Agency - to help manage EMA, and coordinate and support the European medicines regulatory network.
• Technology lifecycle management and information security - to manage information technology and security.

The Network Portfolio governance and related Agile way of working replaces the former EU Telematics governance model and related bodies.

Former EU Telematics strategies are available below for reference. For more information, contact EMA's CIO Office.