As part of wider measures to improve patient safety across the EU, the EMA and a range of other stakeholders (from national authorities, pharmaceutical industry brands, and patient advocates to life science IT and service providers) have invested considerable thought, time, and budget into preparing for the region’s implementation of the ISO identification of medicinal products (IDMP) standards over recent years. When this work finally comes to fruition, there will be much gained – not least in bringing new innovation to care and services based on the sharing of reliable, current medicinal information to any interested party internationally.
The goal of IDMP is to build a comprehensive central database of medicinal products that can be readily searched, understood, and relied upon from country to country. Substance, product, organisation, and referential (SPOR) data management services are key to enabling this. Agreed terminology, product definitions, and data formats will enable meaningful data sharing across departmental, organisational, and geographical borders, supporting a wide range of potential use cases – underpinned by a target operating model. This will assess data during the regulatory process to ensure quality and consistency, and optimise the exchange of application data between regulators and applicants.
|
