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Become Part of the UNICOM Community of Expertise

The UNICOM Innovation Action is about improved patient safety and better healthcare for all.

What is the problem?

Most resource-rich countries maintain at least basic national (electronic) repositories and data bases of medicinal products which have gone through the stipulated regulatory national process to be marketed in that national healthcare system. Unfortunately, these uncoordinated national regulatory procedures have resulted in a host of unintended results and impacts.

And what can UNICOM do about it?

The UNICOM Innovation Action is about improved patient safety and better healthcare for all. This four-year trans-Atlantic project focuses on further development of the International Organization for Standardization (ISO) suite of IDMP (Identification of Medicinal Products) standards, their testing, implementation, and diffusion for regulatory purposes by National Drug Agencies, for global pharmacovigilance, and for advancing European cross-border ePrescription services. At the same time, it will benefit pharmaceutical companies applying for marketing authorisation of new products, providers of medicinal product dictionaries, clinical software producers including start-ups developing intelligent apps for patients, and last but not least patients and health professionals.

How can you be part of the journey?

Every month UNICOM organises an open event which focuses on one specific topic of IDMP implementation that UNICOM contributes to solve. Initial webinars focused on specific use cases such as the detection of falsified products, or how to best ensure the univocal identification of SARS-CoV-2 vaccines – from marketing authorisation, labelling, preparedness for adverse event reporting, validation and clinical research, to pharmaco-economic analysis. Recent editions have addressed topics which require operational responses to IDMP implementation challenges, for the piloting of which the UNICOM medicinal Pilot Products List will be instrumental. A data base of IDMP-formatted and coded information on selected medicinal products will be filled by several national medicines authorities such that the implementation of IDMP and the physical exchange of such data can be tested and piloted, e.g. for cross-border digital healthcare services.

Those events take usually place on Friday afternoon to allow also trans-Atlantic participation. Nine events which have gathered a wide community of expertise have already been organised to date, all with close to 100 participants.. Participation in those events is free, but requires prior registration via the UNICOM website.

From April 2021 on, UNICOM will also start organising dedicated events targeted at  National Medicines Authorities, which are not active in the consortium, to increase awareness of IDMP, disseminate knowledge gained and lessons learned when piloting and implementing IDMP. This will also involve training for electronic tools developed as part of UNICOM work. Furthermore, UNICOM organized on the 21st of April an event targeted at final users such as clinicians, pharmacists, and patients which explain the issues at stake via the use of true-to-life stories.

Due to the highly informative content of those webinars, they remain available on the UNICOM YouTube channel in order for interested people to watch them offline

What have been the first key achievements?

UNICOM is happy to announce that the WHO collaborating centres in Upsala (Uppsala Monitoring Centre for Pharmacovigilance) and in Oslo (Oslo Centre for Drug Statistics and Methodology) are now associated to UNICOM work. Some important decisions on further UNICOM work have also been taken with the support of national regulatory authorities. E.g., the establishment of the European Substance Reference System (EU-SRS), a corner stone for EU-wide implementation of IDMP, is supported by UNICOM; its strategy and implementation plan were recently approved by the Heads of Medicines Agencies (HMA) so that work can progress as foreseen. The first system release date has now been set at 30 September 2021.

Furthermore, UNICOM and the European Medicines Agency (EMA) have agreed that EMA will ensure the technical lead for the development of the Common European Submission Platform (CESP) such that IDMP-compliant application forms for new marketing authorisations, submissions of variations and renewal applications will become available for pharmaceutical companies. This UNICOM/EMA telematics project was named “DADI” (Digital Application Dataset Integration). It will allow to automate and feed regulatory processes with IDMP compliant data and easily re-use them for EU-wide as well as national regulatory and digital health services. It should completely replace the legacy PDF-technology based application forms with a web based application, and become integrated with EMA’s SPOR services.