Editor’s Note: This article was published in Pharmaceutical Technology Europe’s January 2021 print issue.
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EMA’s SPOR implementation guide version two is expected to be published soon, starting the countdown for companies to ensure their data-based submissions are compliant.
A revised series of standards from the International Organization for Standardization (ISO), the identification of medicinal products (IDMP), were formulated for the creation of an integrated global data source for medicinal products (1). Implementation of the standards within Europe is progressing via a phased approach using the European Medicines Agency’s (EMA’s) substance, product, organization, and referential (SPOR) programme (2).
Editor’s Note: This article was published in Pharmaceutical Technology Europe’s January 2021 print issue.
EMA published version one of its implementation guide—EU IG v1—in January 2020 (3), providing stakeholders with information on the specification, data elements, and associated business rules in preparation for the implementation of ISO IDMP standards in the European Union (EU). The second version—EU IG v2—is currently in draft form and under review. Once the second version is published, the European medicines regulatory network will have a minimum of 12 months to prepare for implementation.
To discuss the scope of the revised standards, and any current difficulties or challenges facing organizations in their preparations for compliance, Pharmaceutical Technology Europe spoke with Frits Stulp, managing director of Iperion Life Sciences Consultancy.
PTE: Could you run through some of the key aspects and scope of revised standards and EMA’s SPOR programme?
Stulp (Iperion): The trigger for ISO IDMP was to achieve standardization in the description of medicinal products to enable a smoother regulatory assessment process (i.e., the approval of a dossier or a product variation). From an International Council for Harmonization (ICH) perspective, the standardized product identification would be able to support multiple processes, but in the EU, new legislation came into force in 2016 concerning data submission on authorized medicines, to primarily optimize connection of pharmacovigilance (PV) signals to products, ingredients, batches, and so on, using standardized data, replacing the existing Article 57 database.
In Europe, Article 57 requirements from 2012 have been met up to now using the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) EMA standard, the precursor to IDMP’s Substance, Product, Organization, and Referentials data formatting. XEVMPD provides for more limited data fields than are required for IDMP submissions, but it has paved the way for data exchange as a means of product information delivery and discovery, reducing reliance on static documents.
To date, XEVMPD data sets have been used for multiple regulatory processes and, drawing from that, EMA intends to use SPOR submissions as the basis for master data management, serving multiple use cases. These could include the management of product data in clinical trials to deal with product or substance shortages, to manage orphan drug designation, and to support scientific advice. The aim is to build upon common product information across these various submission processes.
It’s important to note that the scope of SPOR is based on, but not the same as, IDMP, which has a broader definition and has more data fields. Any expansion of SPOR, or any regulatory submissions, should remain in line with the agreed ISO IDMP standards to prevent unnecessary complexity and problems later.
This may sound obvious, but a lot of processes currently are not in line with the provisions of ISO IDMP, and some software vendors are coming out with solutions for managing regulated product data which are not 100% aligned—using the complexity of the standards as an excuse, which will lead to harmonization issues at the marketing authorization holder (MAH) level in due course.
PTE: Could you describe the phased approach to implementation of the standards in more detail?
Stulp (Iperion): The new Target Operating Model (TOM) requires that data submissions must take place at the same time as document submissions, allowing the data to be used in the process. The two-step approach will see this applied initially for centrally-authorized products (CAPs), then later for the other procedure types requiring deeper integration—through electronic application forms (eAFs)—with national competent authorities (NCAs).
Electronic data submission for the centralized regulatory process will take place via the current central European information system or portal, CESSP. With fewer players involved, the initiative will be easier to keep under control and will provide the means to test for any bugs or issues before extending SPOR-based data submissions to a more distributed regulatory scenario.
In phase two, CESSP will give way to a new portal platform, under the Digital Application Dataset Integration (DADI) project, sponsored by EMA and based on more standardized technology.
PTE: Are there any delays to the SPOR programme implementation as a result of COVID-19 or EMA’s reorganization?
Stulp (Iperion): While trying to manage the impact of COVID-19, NCAs have had to deal with people shortages, staff working from home, and other process disruption. Meanwhile, the intense emphasis on healthcare has created new pressure for regulatory professionals and authorities to complete processes more efficiently and transparently than ever, harnessing modern thinking, tools, and techniques. This mind-set is in line with the thinking behind ISO IDMP, which promotes data standards as the means through which to optimize and even automate information processing.
Fortunately, there has been plenty going on in the background to maintain progress. In 2020, EMA completed its reorganization and ‘futureproofing’ exercise. This milestone coincided with the arrival of the agency’s new executive director, Emer Cooke, formerly of the World Health Organization, who took office in November. Along with the other co-chairs of the SPOR Task Force, EMA is committed to ensuring that any investments in the product data standards are reusable across a wide range of use cases—addressing critical business processes.
A further development that is helping to make a seemingly complex landscape easier to navigate and link to longer-term real-world benefits is a growing alignment between two important systems—the EU SRS (scientific database for substances) and EMA’s SPOR Substance Management Services (SMS) system, which distributes relevant substance information.
PTE: What might be the biggest challenges facing companies when preparing operations for mandatory compliance with the revised standards?
Stulp (Iperion): As the baton passes from the regulators back to the life sciences industry, companies must accept that time is ticking on and that waiting for all of the stars to align perfectly before they take action is not an option.
European SPOR implementation guidance is approaching the completion of version two—following a huge effort by industry, technology vendors, and consultants, which has been largely a labour of love. This guidance is expected to be published by 22 Feb. 2021. The clock will then start ticking towards SPOR data-based submissions: these will be possible within 12 months and become mandatory a year after that. That might sound a way off, but the fact that compliant data-based submissions are to be obligatory by 2023 will be sobering for those companies that have relied on a hard compliance date remaining on a distant horizon.
Where companies persist in seeing SPOR and IDMP as a burden to be endured, the next years will be painful and increasingly demanding. Now is the time to put a stake in the ground and decide whether EMA’s mandate is the only driving force for change, or whether this is a defining moment to change the way they do things—to make life easier in the long run.
For many organizations, IDMP will have been seen up to now as just another secondary data set that has to be generated—much as XEVMPD has often been treated. The smarter alternative is to treat the new, richer data sets as an asset in support of primary business processes—the basis of all future regulatory information-based activity, and with application ultimately that extends internationally.
In the United States, Structured Product Labeling (SPL) started out as a secondary data set that companies created to keep the Food and Drug Administration happy—often outsourcing the formatting and submission to third parties. But the realization is dawning that this treatment adds only cost, but no value to the business. In the meantime, other markets including Canada, Brazil, Singapore, and potentially China are all embracing the notion of data standardization and process transformation. Making a fundamental change to regulatory information management approaches now, then, is likely to pay dividends in the long run—once multiple documents can be built from one definitive data set based on agreed international standards.
PTE: What benefits will industry gain from the implementation of the revised standards?
Stulp (Iperion): Companies only have to look at the pain points in routine, everyday activity—those times when regulatory, quality/PV/safety, or clinical teams have to trawl through piles of documents to get to the information they need. Managing recalls is often a particularly painful reminder of the need for greater information visibility and product traceability.
In 2020, managing supply shortages has been a considerable challenge, which more efficient and consistent information exchange would have helped alleviate. And in 2021, the ability to trace where vaccines and COVID-linked treatments have ended up will be a critical need. As red tape has been relaxed to get products out, any gaps in administration will need to be backfilled, to allow PV teams, regulators, and R&D teams to fulfil their obligations.
The most important perspective of all though, as companies look ahead, is that of the patient. Today, as civilians, we have more insight into and control over our financial affairs than we do of our own health, and that must change. The societal perspective on all of this must be to empower patients with all of the information they need about the medicines they take, how and where these products were made, and what goes into them, so that we can start to understand for ourselves what might be triggering or aggravating our allergies, giving us headaches, or sapping our energy.
This reality isn’t that far away. It just needs proper data that all parties can align and refer to in the definition of medicines. It really is that simple—and that’s what we should all keep in mind in 2021, whatever path the COVID crisis takes next and whatever immediate requirements the regulators have prioritized.
1. S. Tranchard, “Revised IDMP Standards to Improve Description of Medicinal Products Worldwide,” iso.org, News Release, 20 Oct. 2017.
2. EMA, “Substances, Product, Organization, and Referential (SPOR) Master Data,” ema.europa.eu [accessed 14 Dec. 2020].
3. EMA, “Substances and Products Data Management Services,” ema.europa.eu [accessed 14 Dec. 2020].
Felicity Thomas is the European editor for Pharmaceutical Technology Group.
Pharmaceutical Technology Europe
Vol. 33, No. 1
When referring to this article, please cite it as F. Thomas, “Coming Up to ISO IDMP Standards,” Pharmaceutical Technology Europe 32 (12) 2020.