The joint HMA-EMA Data Standardisation Strategy (DSS) following its endorsement by the Heads of Medicines Agencies in November and EMA Management Board in December 2021 has been published. This is a major milestone achieved as part of the engagement in international initiatives set out in the Big Data Steering Group workplan.
The DSS sets out the principles to guide the definition, adoption and implementation of data standards according to the European medicines regulatory network needs related to data submitted throughout the lifecycle of medicinal products. The creation of the strategy enables faster uptake of data standards across the EU, will contribute to improve data quality and enable data linkage and data analysis to support medicine regulation. It will support the creation and implementation of internationally applicable data standards in line with the data pillar of the network strategy to 2025.
The DSS is a living document and will be maintained overtime to reflect changes in priorities and additions of new requirements.
Related information: European Medicines Regulatory Network Data Standardisation Strategy | Big Data Steering Group workplan | Regulatory Science Strategy to 2025
Details
- Publication date
- 4 January 2022
- Author
- European Medicines Agency