EMA Updates Guidance on Electronic Submission of Medicinal Product Data under PMS and ISO IDMP
The European Medicines Agency (EMA) has published Version 3.6 of its guidance document "Product Management Services (PMS) – Implementation of ISO standards for the identification of medicinal products (IDMP) in Europe – Chapter 3: Process for the electronic submission of medicinal product information".
The document outlines the processes used for the electronic submission, maintenance and enrichment of medicinal product data within the European Economic Area (EEA), supporting the implementation of ISO Identification of Medicinal Products (IDMP) standards through the EMA's Product Management Services (PMS) platform.
Supporting Regulatory Digitalisation
According to the EMA, the implementation of ISO IDMP standards aims to harmonise the identification and description of medicinal products through standardised data structures and definitions.
The Agency highlights that the use of structured data supports:
Digital transformation across the European medicines regulatory network;
Improved data quality and consistency;
Greater interoperability and data reusability;
Reduced regulatory data maintenance costs.
The guidance covers the entire medicinal product lifecycle, from initial marketing authorisation applications through post-authorisation maintenance activities.
Key Changes in Version 3.6
The main update introduced in Version 3.6 concerns the enrichment of manufacturer and Manufacturing Business Operation (MBO) information within PMS.
The EMA clarifies that, where specific information is not yet available, Marketing Authorisation Holders (MAHs) may temporarily use placeholder values for:
Manufacturing Authorisation Reference Number;
Effective Date;
Medicines Regulatory Agency Organisation.
According to the guidance, these temporary entries will be reviewed and corrected at a later stage to support overall data quality.
Increased Focus on Manufacturing Data
The updated guidance also reinforces requirements relating to manufacturer information, manufacturing business operations, structured pack size data and product identifiers.
These data elements are being integrated into PMS to support initiatives such as the European Shortages Monitoring Platform (ESMP), which aims to strengthen the monitoring and management of medicine shortages across Europe.
The guidance highlights the increasing importance of maintaining accurate and structured manufacturing information within regulatory systems, reflecting a broader shift towards data-driven regulatory oversight.
Why This Matters for Medical Device Manufacturers
Although the guidance applies specifically to medicinal products, it provides insight into the direction of travel for European regulatory systems.
Several themes are equally relevant to medical device and IVD manufacturers, including:
Increased use of structured regulatory data;
Enhanced interoperability between regulatory platforms;
Digital management of manufacturing and product information;
Greater reliance on standardised identifiers;
Expansion of centralised regulatory databases.
As European authorities continue to invest in digital regulatory infrastructure, manufacturers across the healthcare sector can expect increasing emphasis on data quality, standardisation and system interoperability.
Next Steps
The EMA states that the guidance will continue to evolve as additional PMS and ISO IDMP implementation activities are introduced. Version 3.6 is now applicable and replaces previous versions of the document.
