Enterprise Resource Planning (ERP)
eSubscription is the process of registering medicinal products for marketing authorisation at the local authorities.
eSubscription requires in current regulations in the US and Europe substantially different technologies, terminologies and vocabularies for registration of medicinal products. In the US, the FDA requires a “Structured Product Labeling” (SPL). In Europe, the European Medical Agency (EMA) initiated a new standard called IDentification of Medicinal Products (IDMP). It is most likely that FDA will take-over these standards in near future. IDMP raised the bar significantly by requiring information be sent in specific form for each country and language and coded with an ISO Code.
The EMA and the EU Regulatory Network have founded an EU IDMP Task Force with the involvement of terminology organisations, software vendors and developers of medicinal products dictionaries or databases. The task force will be responsible for advising on the planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.
More details on the EU IDMP Task Force are to find here.
The European Union Network Data Board (EUNDB) is an advisory body co-chaired by the Head of Business Data and Support Department of the EMA.
EUTCT is a central repository and publication system for controlled term lists used in the European medicines regulatory network.
It is a repository and provider of controlled terms (or controlled vocabularies) in multiple languages. It is the predecessor of RMS. RMS will replace EUTCT with regards to management of controlled vocabularies. EUTCT can only be fully replaced after SMS implementation as it also contains substances