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regenold GmbH
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79410 Badenweiler
Germany
Phone: +49 7632 82 26-0
Fax: +49 7632 82 26-555
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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: Navigating Compliance for European Marketing Authorisation Holders
European Marketing Authorisation (MA) Holders: are you keeping track of the EMA's updates and deadlines for ISO-IDMP compliance and the EMA SPOR system? PMS data enrichment and web-based eAF deadlines are fast approaching in 2025 and beyond.
As a small or medium sized pharmaceutical company, the mechanism to achieve ISO-IDMP compliance will differ from larger organisations utilising regulatory information management systems (RIMS). We will be explaining the background of the EMA SPOR system implementation, what needs to be done and by when, with a series of explanatory articles and infographics over the coming weeks as developments arise.
What is ISO-IDMP and SPOR? A Quick-Stop Tour
ISO-IDMP: International Organisation for Standardisation – Identification of Medicinal Products
ISO-IDMP is a set of five ISO data standards that standardise the definitions and terms used to identify and describe medicinal products – including product name, national MA number, packaging, and manufacturing information. ISO-IDMP standards are set to be applied globally to ensure wide interoperability across global competent authorities (CAs) and between stakeholders. Further reading: EMA ISO-IDMP Standards Overview.
SPOR: Substance, Product, Organisation and Referential Master Data
SPOR is a set of four modules created by the EMA to store and manage medicinal product master data that complies with the ISO-IDMP standards. SPOR is how the EMA is implementing ISO-IDMP standards in practice. Further reading: SPOR portal.
The EMA has used an agile approach to implement SPOR, meaning the modules are constantly evolving. Other competent authorities are also at different stages of implementation and will have their own approaches. Any companies with EU licences – or related contract manufacturing organisations supplying products for EU licences – are required to be set up to use the EMA IT ecosystem, including SPOR.
As acting MAH for some of our clients, we have already actioned updates for the 31 May 2025 deadline for critical medicines and we continue to keep up to date with developments and deadlines.
Connection Between ISO-IDMP, SPOR, and Other EU Systems
ISO-IDMP data standards are applied to the data within the SPOR modules. What is registered and stored within SPOR is used in other EU systems, so the data should be checked for correctness and alignment to ISO-IDMP standards to ensure that factually correct and properly formatted data feeds through to other processes.
The PMS (Product Management Services) module has many use cases and will eventually replace XEVMPD, acting as the single source of truth for medicinal product data. The SPOR modules and related systems make up a key part of the various EMA network portfolio streams. Further reading: EMA Network Portfolio Roadmap 2025–2027.
How regenold Can Support You
As deadlines approach for PMS data enrichment and web-based eAF implementation, ensuring your organisation is prepared for full ISO-IDMP compliance is crucial for maintaining your European marketing authorisations. Our regulatory experts can:
- Help you understand the requirements and deadlines across the various EMA systems
- Assist with enriching your data within PMS to meet ISO-IDMP standards
- Provide ongoing support as the EMA systems continue to evolve
Don't risk non-compliance. Contact our regulatory experts today to schedule a consultation and ensure your company is ready for SPOR integration and the upcoming deadlines.
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Don't Risk Non-Compliance
Schedule a consultation with our regulatory experts and ensure your company is ready for SPOR integration and the upcoming ISO-IDMP deadlines.
Speak with an Expert