In response to the urgent and necessary need for address the various challenges associated with collecting post-marketing data, the European Medicines Agency (EMA) has announced a strategy to make better use of the existing registries and facilitating the establishment and utility of new registries as a source of high quality post-authorisation data for regulatory decision-making.
EMA and other regulators around the world sometimes ask sponsors to establish a registry post-marketing authorisation to further assess the safety and/or efficacy of individual products. This is especially the case in many orphan drugs. However, many registries lack harmonised products and data structures and are often underutilised or unsustainable. Duplication of efforts and inefficiencies are also characteristics of these registries due to which this initiative by the EMA may improve this situation as it aims to “(make) better use of existing registries and facilitating the establishment and utility of new registries as a source of high quality post-authorisation data for regulatory decision-making” as well as initiating new registries if needed.
The initiative includes two components: a strategy on registries and a pilot phase.
According to a document released by the EMA the strategy will aim to utilise existing patient registries “within the current legal and regulatory framework for medicinal products” and is proposed to start from when an advice or request it made to collect additional data. The five important steps in this process, which is mainly a capacity building exercise separate from the regulatory process, include:
1. “Early dialogue with MAAs/MAHs;
2. Definition of data collection characteristics by or with the committee or working party: objectives, population, outcomes, any hypotheses to be tested; as appropriate, input from different stakeholders may be considered;
3. Identification of existing data sources that could fulfil the objectives, and evaluation of their adequacy by MAAs/MAHs in collaboration with regulatory authorities and data source custodians;
4. Need for data or information that is best addressed through a registry;
5. a. Amendment or addition to existing registry/registries;
b. Definition of core components of a new registry”
In the pilot phase, the EMA will evaluate whether the above the strategy will facilitate the requirements of high quality data collections repositories, through real world examples. It will be coordinated by the EMA in collaboration with the Cross-Committee Task Force on Registries. The pilot phase will last two years and the participation in the pilot phase will be determined on a case by case, driven by the precise objectives of the pilot phase in terms of methodological tools and approach to be tested. The above outlined steps will be applied to a number of diseases and products to test whether this collaborative approach will be successful.