We're here to help answer any questions you might have.
We look forward to hearing from you.
Headquarters:
regenold GmbH
Zöllinplatz 4
79410 Badenweiler
Germany
Phone: +49 7632 82 26-0
Fax: +49 7632 82 26-555
Email:
info@regenold.com
Francesca Ward
Senior Regulatory Officer
Francesca is a Senior Regulatory Officer at regenold with over 5 years of experience navigating both UK and EU regulatory frameworks. She has a strong track record in client and project management across a diverse range of products, providing support in strategic MAA planning, dossier due diligence, eCTD publishing and submission, and ensuring ongoing compliance with industry regulations. Francesca also liaises effectively with external regulatory bodies to maintain alignment with evolving requirements.
In addition to her main regulatory responsibilities, Francesca plays an active role in the business development and contributes to the regulatory intelligence subgroup. Her work in this area is with a focus on the future of digital regulatory systems and ISO-IDMP data standard implementation across the EU and UK.
Francesca continues to develop her regulatory knowledge by undertaking the TOPRA Level 7 Regulatory Affairs Specialist Apprenticeship and a MSc in Regulatory Affairs alongside her day-to-day responsibilities and is close to completing both qualifications.
Outside of work, Francesca enjoys an active lifestyle, particularly hiking, running and netball, the latter at which she competes at a UK regional level. She is also a travel enthusiast and is currently learning Mandarin, reflecting her commitment to continuous personal growth.
ISO-IDMP & EMA's SPOR System: Marketing Authorisation Holders Actions 2025–2027
Following the April SPOR (Substances, Products, Organisations and Referentials) status update, the European Medicines Agency has outlined key actions that Marketing Authorisation Holders (MAHs) must complete during 2025–2026 to ensure compliance with evolving regulatory data management requirements.
These actions focus primarily on data review between the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and the Product Management Services (PMS) systems following migration, PMS data enrichment of structured pack sizes and manufacturer and manufacturing business operation (MBO) details, and the continued rollout of digital tools including the web-based electronic Application Form (eAF) and Electronic Product Information (ePI) systems.
As of October 2025, the EMA announced extended deadlines for critical medicines on the Union List of Critical Medicines (ULCM) until June 2026 and non-centralised (non-CAP) product deadlines until December 2026 and June 2027.
Updated Deadlines and Activities
| Activity | ULCM / CAP Products | Non-Critical / Non-CAP Products |
|---|---|---|
| PMS vs XEVMPD data comparison | No fixed deadline – should be performed as soon as possible (from Q2 2025 onwards) | |
| XEVMPD package description submission | ULCM: 31 May 2025 | Non-critical medicines: ongoing from Q2 2025 |
| PMS enrichment: structured pack size information | ULCM: by end Q3 2025 | Non-critical medicines: by end Q4 2026 |
| PMS enrichment: manufacturer & MBO data (non-CAPs) | ULCM: by end Q3 2025 | Non-critical medicines: by end Q4 2026 |
| Web-based eAF | CAP – MAVs: strongly recommended from Q3 2025 | Non-CAP – MAVs: strongly recommended from Q4 2025 |
Don't Navigate ISO-IDMP Compliance Alone
With multiple deadlines approaching and the complexity of EMA's evolving systems, ensuring your organisation is prepared requires specialist knowledge and strategic planning. As acting MAH for numerous clients, we have already implemented these processes successfully and stay continuously updated on EMA's evolving requirements.
Let us help you transform this regulatory challenge into a streamlined process.
Insights
Ready for SPOR Integration?
Contact our regulatory affairs team to arrange a consultation and ensure your company meets the upcoming ISO-IDMP deadlines with confidence.
Speak with an Expert