Are you a company seeking to commission or collaborate in the conduct of a post-authorisation study (PAS)?

Do you wish to register a study in the EU PAS Register?

Are you considering applying for an ENCePP study seal?

Are you interested in the recommendations from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) on safety signals?

Review the list of signals discussed

EU PAS Register unavailable on 18 January from 18:00 to 22:00

Due to essential IT maintenance, the EU PAS Register will be unavailable on 18 January from 18:00 to 22:00 CET, and EU PAS studies cannot be registered or updated during this period. This work is part of planned maintenance to strengthen the security of the EMA's applications.

ENCePP 2021 Activity report published

The ENCePP report on the network's 2021 activities has been published. The report covers the key achievements, short summaries of the meetings organised through the year, information on publications and some statistics on the EU PAS studies.

Related information: ENCePP 2021 Activity report

ENCePP Plenary webinar report published

The report and the presentations of the ENCePP Plenary webinar held on 18 November 2021 have been published.

Related information: Report and presentations

Joint HMA-EMA Data Standardisation Strategy (DSS) published

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