EMA Guidance: EMA’s Implementation of ISO IDMP Standards Through Products Management Services (PMS)

To modernize and harmonize the management of medicinal product information, the European Medicines Agency (EMA) is actively implementing the International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP). This major regulatory shift—carried out through the Product Management Service (PMS)—is designed to support data consistency, improve regulatory decision-making, and ultimately enhance public health outcomes across the EU.

Flowchart illustrating the step-by-step process for PMS registration

Understanding IDMP and PMS

ISO IDMP (Identification of Medicinal Products) is a suite of international standards that define how medicinal products are identified and described globally. These standards are crucial for supporting regulatory activities, pharmacovigilance, and the safe exchange of medicinal product information between stakeholders.

The European Union mandates their use to ensure structured, interoperable, and high-quality data exchange between regulatory authorities, marketing authorisation holders (MAHs), and other stakeholders.

The EMA’s PMS acts as a central service under the broader SPOR master data programme, which stands for:

• Substance

• Product

• Organisation

• Referential

The scope of PMS is focused on managing structured data for products authorised for human use, facilitating streamlined regulatory submissions, and improved product traceability across Europe.

To submit medicinal product data to the Product Management Service (PMS), organizations must adhere to specific registration requirements:

• Onboarding to SPOR Data Services: Users must be affiliated with a recognized organization and assigned the appropriate user roles. Registration into the PMS system involves a multi-step, role-based process:

  1. Initial Administrator Registration (Step 1): The first step requires designating an Administrator User within each organisation via EMA’s Organisation Management System (OMS). This role is necessary to manage internal access permissions and must be validated by EMA using a signed Letter of Affiliation.

  2. User Access Based on Intended Tool (Step 2): Depending on whether the user seeks access through the API (Application Programming Interface) or the Product User Interface (PUI):

  • API Access: Enables system-to-system integration for automated data transmission.

  • PUI Access: Web interface where users can view and manage authorised product data.

  Registration must be performed via the EMA Account Management portal (IAM) and users should select appropriate roles according to their organisation’s needs and tools used (e.g., eAF, ePI, IRIS).

• Access Management: Access to PMS is tightly controlled to maintain data integrity, security, and accountability. Only authorized users can submit and maintain product information.

• Training: Organizations are responsible for ensuring that users are adequately trained to use PMS and comply with submission requirements.

The PMS system facilitates the electronic submission of medicinal product data in compliance with ISO IDMP standards. This process is designed to:

• Streamline the maintenance and accessibility of product information

• Support regulatory submissions, updates, and lifecycle management of medicinal products

• Ensure all data exchanges are standardized and interoperable across the EU

The adoption of ISO IDMP standards delivers several key benefits:

• Improved Data Quality: Standardized data elements reduce errors and inconsistencies.

• Enhanced Regulatory Oversight: Facilitates efficient pharmacovigilance and compliance monitoring.

• Global Harmonization: Aligns EU processes with international best practices, supporting global product lifecycle management.

EMA’s roll-out of PMS under ISO IDMP is a pivotal move toward modernising pharmaceutical regulation in the EU. For more details, you can read the full guidance published by the European Medicines Agency here.