Twelve National Competent Authorities for medicinal products are actively involved in the UNICOM project. They are pioneering the implementation of the identification of medicinal products (IDMP) in the European Medicines Regulatory Network (EU MRN).
Implementing IDMP standards in this business domain is challenging. Numerous topics have to be solved covering business, IT aspects, and data management.
On Friday October 2nd 2020, business and IT experts from participating National Competent Authorities held the first in a series of knowledge- and best practice-sharing sessions. Each knowledge-sharing session focuses on the experience and learnings of just one participating authority.
The Health Products Regulatory Authority (HPRA) of Ireland started off the workshop series, followed by Sweden. Workshops with Estonia, Austria, and Croatia will follow in the coming weeks. The sessions are extremely informative as they enable the open sharing of questions and solutions to identified issues.
The first two sessions have already emphasised the importance of putting considerable effort into informing within and outside the organisation of the long-term impacts of IDMP implementation. Convincing administrative, scientific and regulatory experts in the domain of the value of IDMP is no trivial issue, especially at a time when health systems in Member States are under huge stress.
Parallel to the knowledge exchange occurring inside the UNICOM consortium, the project objectives were presented to the EU Network Data Board. This board is an advisory body, co-chaired by European Member States and the European Medicines Agency. It has the vision to establish the appropriate data standards and supporting terminologies needed to back up the sharing and analysis of data/information as an important asset for the network.
In these challenging times, the network of national competent authorities is eagerly looking forward to strengthening the standards and terminologies needed for medicinal products. A key activity in making progress is their own, mutual, knowledge exchange.