Pressure is starting to ramp up for marketing authorization holders to update and maintain their product data for the Product Management Service (PMS) database. With the European Medicines Agency (EMA) making clear that the database that will become the single source of truth of master data to support various regulatory application processes, industry is advised to make sure their data is complete and accuratei.
In the near term, there are several important activities that industry needs to be aware of and should be addressing with a greater sense of urgency.
Critical medicines
In an effort to ensure patients have sufficient access to essential medicines, the European Commission has published a Union List of Critical Medicines (ULCM)ii. If a product is on that list, the European regulatory authorities will use the European Shortages Monitoring Platform (ESMP) to assess if there is a risk of a shortage or if there are actual shortagesiii.
For the platform to be operational, the authorities require more detailed information about those products, some of which will come from the PMS. It is therefore important that companies check whether their products are covered by the ULCM, which they can do by checking the ATC-level 5 code (Anatomical Therapeutic Chemical classification system, essentially the active substance)iv. If it is, it is incumbent on those companies to ensure that their product information, including pack size, is correct, sufficient, and up to date in the PMS.
XEVMPD as a source of data and addition of manufacturing information to OMS
The EMA is asking companies to check their XEVMPD data, especially in countries where authorization numbers were assigned at the product level. In those cases, companies will have to ensure that a separate product data record exists for each different pack size. This will mean they have to duplicate their entries for the same medicinal product and distinguish them according to the pack sizes. This duplication, which has to be completed before the end of January 2025 for those products covered by the ULCM, will mean that companies will end up with several EudraVigilance codes for these products in futurev.
The challenge with this for companies could be that a future change to a product would affect all the different pack size entries for this product, which would mean companies could have multiple EV codes in the database to maintain. We believe it is likely that missing any of these would render the data in the database inconsistent and therefore incorrect.
Additionally, and also as soon as possible, it is our recommendation that MAHs ensure that all organizations involved in the manufacturing of their products, as well as the MAHs themselves, have complete and correct entries in the OMS (organisations management services) database.
In a communication on 16 June 2024, the EMA also told MAHs that they will need to cross-check their product records references from the XEVMPD to the SMS (Substance Management Services) and RMS- (Referentials Management Services) databases, in order to avoid using invalid termsvi. While there is no deadline for this review as yet, it is highly recommended that companies perform both these checks as soon as possible as well as map their MAH information with the Organisation Management Services (OMS).
Analyze accuracy of migrated data
Companies now also have the option of a read-only mode for their products authorized through the Centralised Procedure through the product user interface of the PMS (PMS-UI). The EMA has also announced that from September this year companies will also have a read-only option in PMS-UI for products authorized through the National Procedurevii. Companies using dedicated software can already obtain PMS read access via a computer-to-computer interface (PMS-API) for both centrally and nationally authorized products.
Companies are advised to conduct a field-by-field analysis to review the migrated information, cross checking the information between the XEVMPD and the PMS. This is an important step for companies to take since the data will be consumed by other systems besides the ESMP, so it needs to be accurate. A review should assess that the different strengths of their product are grouped under the same PMS ID.
Looking to the future
One key consideration for companies from our experience is how the changes to product data at the pack size level, with its impact on EV codes, will affect their regulatory information management (RIM) systems if they are integrated with the XEVMPD. It is therefore incumbent upon companies to evaluate how these requirements will impact their systems and processes.
In the coming year, it is expected that more data will need to be added to the PMS. We will share more details on these and other expected changes in our next blog.
In the meantime, we would like to hear how you are preparing for the transition to PMS. Are you impacted by the ULCM requirements? Have you considered how data submission at the pack level will affect your systems and processes?
About the author:
Clara Borao is Manager in Regulatory Informatics Services, at PharmaLex. Clara has 12 years of experience in the XEVMPD with sound knowledge in product data management, experience in pharmacovigilance, with the national competent authorities, and as a consultant.
Notes:
i Substance and product data management services, EMA. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data/substance-product-data-management-services#pms-implementation-plan-12044
ii Commission publishes first Union Critical Medicines list to tackle shortages, European Commission, Dec 2023. https://ec.europa.eu/commission/presscorner/detail/en/ip_23_6377
iii Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004, EMA, July 2024. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.ema.europa.eu/en/documents/other/chapter-3ii-xevprm-user-guidance-detailed-guidance-electronic-submission-information-medicinal-products-human-use-marketing-authorisation-holders-ema_en.pdf
iv ATC code, EMA. https://www.ema.europa.eu/en/glossary/atc-code
v Public webinar on pack size submissions: from XEVMPD to product management service (PMS), EMA. https://www.ema.europa.eu/en/events/public-webinar-pack-size-submissions-xevmpd-product-management-service-pms
vi Product Management Service (PMS) Info-Day, EMA. https://www.ema.europa.eu/en/events/product-management-service-pms-info-day
vii PMS – NAPs Data Viewing capability available in PMS PUI in September 2024. https://plm-portal.ema.europa.eu/Guidance/article/KA-01075/en-us/
https://www.ema.europa.eu/en/events/past-events?f%5B0%5D=events_list_dates%3A2024-07-08~2024-07-08
