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 European Union and had decided to invite in Stockholm on May 12 all the Heads and CIOs of the European Union National Agencies and beyond with more than 40 different countries represented.

Sweden had included IDMP implementation in the agenda of this strategic meeting and has shortly presented to all the NCAs the impact and the recent developments and results achieved by the NCAs active in the UNICOM project.

In some countries, the responsibility of market authorisation and pharmacovigilance is spread across several agencies and hence the IDMP impact can be evaluated differently as for example IDMP implementation is currently legally limited to the Human domain and does not include the veterinary domain. UNICOM is pleading for a wide implementation of IDMP, including thus also the veterinary domain and connecting the regulatory and clinical worlds.

The results of a poll organised at the end of the session dedicated to IDMP are very much encouraging: a vast majority of the participants declared that IDMP implementation was already in progress or included in their current strategies.  Almost all agencies also declared they were willing to join new IDMP implementation support initiatives.  

UNICOM is more than ever committed to accelerate IDMP implementation in Europe and beyond. During its last year of activity UNICOM will be multiplying the number of events aiming at supporting all National Competent Authorities with concrete examples of successful implementation strategies within NCAs and targeted educational webinars on topics such as the knowledge and use of the FHIR standard related to medicinal products. UNICOM wants also to ensure that the momentum is not lost after the end of the current project and is thus also considering several approaches to ensure the sustainibilty and further dvelopment of the resources produced by the project.