Preparing the PMS: A commercial and regulatory imperative
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Hanna Saari
PMS is a central plank in the EMA’s four-part SPOR program (substance, product, organizations and referentials), which supports the implementation of Identification of Medicinal Product (IDMP) standards in the European Union. The purpose is to establish data standardization and facilitate the exchange of data across the network of European regulators. It will also support greater product data transparency across Europe and the digitalization of European regulatory procedures.1
PMS is a central plank in the EMA’s four-part SPOR program (substance, product, organizations and referentials), which supports the implementation of Identification of Medicinal Product (IDMP) standards in the European Union. The purpose is to establish data standardization and facilitate the exchange of data across the network of European regulators. It will also support greater product data transparency across Europe and the digitalization of European regulatory procedures.1
As EMA made clear in its PMS information day presentation in April 2024,2 PMS is intended to be used by regulators and industry, both in regulatory and non-regulatory procedures, as well as to support European citizens with a trusted source of product information. It is therefore important that companies don’t try to classify PMS as a purely regulatory activity. Rather, a master data initiative should be driven from a management level, so this important data can be leveraged for commercial and regulatory purposes.
Indeed, there is much talk within pharmaceutical companies about using artificial intelligence and other digital tools for multiple purposes, but this will require good quality data. Compliance with PMS will provide the data integrity that will be needed to achieve the goal of leveraging data for different purposes, including AI-led projects.
For its part, the EMA has outlined several benefits and business outcomes that PMS can support, including better and faster decision-making based on more data available, support for regulatory and non-regulatory procedures, and operational efficiencies, among others.
Master data in broad use
As EMA has noted, re-use and updating of the master data will reduce duplication of work and reduce errors introduced by manual operations by providing a single data source through systems and regulatory processes.
The master data from PMS will be leveraged for several other EMA systems, including the electronic Application Form (eAF), European Shortages Monitoring Platform (ESMP), and electronic Product Information (ePI).
3 things to keep in mind
eAF leverages data
When companies submit new applications, they do so through the Product Lifecycle Management (PLM) portal.3 At the time of writing, the portal applied only to Centrally Authorised Products (CAPs), with availability for all products in the EU planned.
The eAF leverages data from the PMS, but if companies see out-of-date master data in the portal, they can propose changes to the regulatory authorities, which, if accepted, will result in changes to the master data.
ESMP monitors shortages
Drug shortages have been a significant problem in the European Union, and during COVID-19 availability of critical medicines became a serious issue.
ESMP will be put in place to help EMA monitor the availability of critical medicines during crisis situations, including public health emergencies.4 The platform will take the master data from PMS, so the authorities can stay on top of medicine shortages. As of October 2026, ESMP is in use. EMA launched its first full set of ESMP functions for companies and national authorities on January 29, 2025.4
ePI aids accessibility
The ePI helps address this friction point by providing digital versions of the package leaflet. However, the PMS remains the foundation of product information and source of truth.
Prepare for expanded data use
Furthermore, while the SPOR is a European initiative, IDMP is a global standard and will ultimately be adopted globally. Getting your PMS data in order now will therefore help to support regulatory obligations, bring benefits to the business across Europe, and ultimately serve to prepare companies for global implementation of IDMP standards.
Precizare:
Informațiile furnizate în acest articol nu constituie consultanță juridică. Cencora, Inc. încurajează insistent cititorii să revizuiască informațiile disponibile legate de subiectele discutate și să se bazeze pe propria experiență și expertiză în luarea deciziilor legate de acestea.
References
1. European Medicines Agency. "Substance and Product Data Management Services." August 8, 2024. Updated October 6, 2026.
2. European Medicines Agency. "Product Management Service Info Day." April 16, 2024.
3. European Medicines Agency. "eSubmission, PLM Portal eAF." December 16, 2025. Updated September 1, 2026.
4. European Medicines Agency. "European Shortages Monitoring Platform." June 11, 2024. Updated December 16, 2025.
5. European Medicines Agency. "Electronic Product Information (ePI)." September 4, 2026.
