Patient registries

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Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time. Patient registries can play an important role in monitoring the safety of medicines. The European Medicines Agency (EMA) has set up an initiative to make better use of existing registries and facilitate the establishment of high-quality new registries if none provide adequate source of post-authorisation data for regulatory decision-making.

The patient registry initiative will explore ways of expanding the use of patient registries by introducing and supporting a more systematic and standardised approach to their contribution to the benefit-risk evaluation of medicines within the European Economic Area.

Pharmaceutical companies and regulators currently face a number of challenges in using existing registries or establishing new ones, including a lack of:

  • coordination between ongoing initiatives at national and international levels;
  • harmonised protocols, scientific methods and data structures;
  • data sharing and transparency;
  • sustainability.

These factors have led to inefficiency and a duplication of efforts. To address these problems, the EMA initiative seeks to create a collaborative, European Union-wide framework on patient registries. It aims to facilitate collaboration between registry coordinators, such as physicians’ associations, patients' associations, academic institutions or national agencies responsible for overseeing healthcare services, and potential users of registry data, such as medicines regulators and pharmaceutical companies.

A cross-committee task force on registries was set up in 2014 to develop and support the initiative. It includes representatives from EMA committees and working parties, the European Commission and national competent authorities. 

Strategy on registries

The initiative proposes a strategy to identify and evaluate existing data sources and develop a methodological toolkit for establishing new registries if needed. The strategy starts from the stage where an EMA committee identifies the need to gather additional data on a medicine from real-life clinical use, before or following the medicine’s authorisation, or when an applicant or marketing-authorisation holder independently identifies this need. The proposed approach includes the following steps within the current regulatory framework:

  • identify and evaluate existing data sources including national databases, electronic health records and existing patient registries;
  • determine if the need for data is best addressed through a registry;
  • investigate with registry coodinators the possibility to amend or extend an existing registry if needed;
  • defining the core components of a new registry as applicable.

The identification of adequate existing data sources is the responsibility of the applicant or marketing-authorisation holder, but interactions between stakeholders concerned, including registry custodians, Member States, EMA committees and working parties, may be facilitated by EMA as part of the strategy.

In addition, EMA will facilitate access on this page to:

  • an inventory of existing patient registries;
  • a toolkit of methodological guidelines to evaluate data quality;
  • standard sets of data elements for new registries.

Pilot phase

The initiative starts with a pilot phase to test different components of the patient registry strategy and if it meets regulators' and other stakeholders' data and information requirements. 

EMA will include medicines in the pilot based on expressions of interest by applicants or marketing-authorisation holders and a selection by the cross-committee task force, in cooperation with the responsible EMA committee rapporteurs and the pharmaceutical companies concerned.

The cross-committee task force on registries will discuss lessons learned, and EMA will publish recommendations for continuing the work on patient registries following the pilot phase.

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