A vast majority of European National Competent Authorities engaged in IDMP implementation
The Swedish Medicinal Products Agency is leading the UNICOM work package dedicated to IDMP implementation within National Authorities competent for market authorisation. Sweden is currently ensuring the Presidency of the […]
Norway, Belgium, Greece, Italy, Finland and the USA collaborate with UNICOM to provide a limited (4 substances) but complete IDMP/FHIR data set.
The process consists in collecting Data “AS IS”, and doing a central standardization to EDQM, limited to the minimal attribute list (variables relevant for pilots) and limited to 4 single […]
EU-SRS is live at EMA: a major IDMP related milestone reached!
It is celebration day today (Jan 25) in Amsterdam at EMA headquarters. UNICOM is very pleased to announce that EU-SRS (the European Substances Registration System) is operational at EMA. The […]
Intensive preparation and training to prepare the release by EMA of variations form for human medicinal products in october 2022
The Digital Application Dataset Integration (DADI) Network project will replace PDF electronic application forms (eAF) used for regulatory submissions with web-forms, making the future form-filling and submission-handling process more efficient. […]
A new scientific article published this week in the Journal Applied Science advocates for the use of the EDQM Standard Terms Database for Pharmaceutical Dose Forms
In the context of the UNICOM project, researchers from the European Institute for Innovation through Health Data analysed the Standard Terms for Pharmaceutical Dose Forms from the European Directorate for Quality […]
