The coronavirus response highlighted the need for global data standards in medicine, giving renewed impetus to work on IDMP (Identification of Medicinal Products) standards. Frits Stulp of Iperion Life Sciences Consultancy looks forward to this year’s progress with IDMP in Europe.
In 2020 the emphasis was on healthcare and the global spotlight fell on pharma organizations, marketing authorization applicants and holders (MAAs and MAHs), and of regulators. Getting medicines and vaccines to market quickly while not compromising on safety and quality became more important than ever.
It became clear that global data standards can support the pharmacovigilance element of bringing new vaccines to market safely. The ISO IDMP (Identification of Medicinal Products) standards, which Europe is close to implementing via the EMA SPOR program, will go a long way to driving more efficient data-based regulatory submissions.
Consistent Constituent Data
IDMP standards aim to identify medicines and their constituents consistently. They provide a means of sharing standard data about manufacturing such as where products were made, the batch they came from and detail about their ingredients. In turn, this data helps manufacturers and health bodies monitor side effects and supports regulatory interventions.
This year we are likely to have multiple new vaccines being distributed across the globe, to be given to billions of people – the largest human population ever to be targeted at once. Inevitably there will be side effects and reports of adverse events which regulators and the life sciences industry will need to respond to. Linking this data with data tracking the supply of the vaccines will be an important starting point.
Then the ISO IDMP data model allows for medicinal products, their packaging, any different versions, ingredients, specific batches, and who have manufactured them, to be differentiated as part of any vaccine effort. The data could also contribute to electronic vaccination-based passports.
Beyond Compliance
There is no doubt that the global response to the COVID 19 pandemic has highlighted the potential of data standards, such as IDMP, in real-world use cases. Until now it has been an uncomfortable truth that many life sciences companies view the requirements as a compliance burden that they will address only when necessary – when IDMP databased marketing authorization submissions are mandatory expected to be the case across the EU by 2023. That attitude is changing and there is real progress being made towards IDMP in Europe.
The European Medicines Agency (EMA), with the National Competent Authority (NCAs) and industry co-chairs of ISO IDMP SPOR Task Force (which is focused on finalizing the introduction of Substance, Product, Organization and Referentials data) Task Force, has committed to ensuring that product data standards are reusable across a wide range of everyday business use cases.
Supporting Business Processes
The EMA is now recognizing that standards-based master data about products could help support a multitude of processes between industry and regulators ranging from clinical trial approvals and shortages management, to product serialization and tracking. EU-wide agreement on data exchange between regulators and industry would be ideal, to ensure optimization of processes and use cases. To this end, an EMA-sponsored project has replaced the Common European Single Submission Portal (CESSP). At the same time, there 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 relevance substance information.
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As European agencies throw their weight behind IDMP, there is a growing awareness across all stakeholders of the value of high-quality reusable data in streamlining routine processes. This development is creating a new sense of purpose and urgency around the ISO standards – in Europe at least. The WHO is looking into Substance IDs and Pharmaceutical Product Identification (PhPIDs) as part of a global solution.
NCAs have been coping with staff shortages and people working from home at a time of unprecedented global focus on healthcare. Regulatory professionals and authorities have been under pressure to complete processes more efficiently and transparently than ever. ISO IDMP, which promotes data standards as the means through which to optimize and even automate information processing, will support all of this. In 2021, IDMP-based master data is not just a key building block of compliance activities. It will increasingly support critical business processes.
Life sciences companies need to act now to put themselves in the best position to maximize the potential of IDMP. This is against a backdrop of change in the model for submitting regulatory data within the regulatory processes - the so-called Target Operating Model (TOM) – and the need for technology environments at EMA and NCAs to support this.
Two Steps to Data Standards
To maintain momentum towards data standards, the SPOR Task Force has compromised on a two-step approach. The first step defines electronic data submission for the centralized regulatory process only, via EMA’s Gateway and/or API. During this step it will be possible to pick up issues before extending SPOR-based data submissions to a wider regulatory scenario involving NCAs.
In the second phase, as the CESSP gives way to the new technical platform, MAHs will be able to submit data once to stakeholders at both EMA and NCAs. At this point, the application forms must be able to supply IDMP-ready messages. In late 2020, stakeholders were working to secure a commitment to a capped transition period, so that the two systems don’t run in parallel indefinitely.
In early 2021, European SPOR implementation guidance is approaching the completion of version two. SPOR data-based submissions will be possible within 12 months, and become mandatory a year after that. Compliant data-based submissions will be mandatory by early 2023.
The next two years will be a challenge for life sciences companies that see SPOR and IDMP as solely a compliance burden to be endured. This is a defining moment for life sciences companies to change the way they do things now to make life easier in future. IDMP is not just another secondary data set that has to be generated – much as IDMP’s predecessor, the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD), was treated by many companies. The alternative view is to treat the new, richer data sets as the foundation for enhancing business processes and global regulatory information-based activity.
A good way to bed in new thinking is to look for the pain points in routine, everyday activity. One approach is to work with people across the organization to identify processes where regulatory, quality, pharmacovigilance, safety or clinical teams have to trawl through piles of documents to get to the information they need. Managing recalls is a good example. This process is too often a painful reminder of the need for greater information visibility and product traceability.
In 2020, managing supply shortages was an extensive challenge, which more efficient and consistent data exchange would have helped with. And in 2021, the ability to trace where vaccines and COVID 19-linked treatments have ended up will be critical.
A Global Perspective
In the US, Structured Product Labeling (SPL) started out as a secondary data set that companies created to keep the FDA happy – often outsourcing the formatting and submission to third parties. It is becoming increasingly acknowledged that this treatment adds only cost, but no value to the business.
Elsewhere, markets including Canada, Brazil, Singapore and potentially China are all embracing the need for data standardization, supporting process transformation. Biting the bullet and investing time and resources into improving data-based regulatory information management approaches now, is likely to pay dividends when multiple documents can be built from one definitive data set based on agreed international standards.
The patient must remain at the heart of all efforts to standardize data. It can seem that we have more insight into and control over our financial affairs than we do of our own health. Patients want and should have all of the information they need about the medicines they take, how and where these products were made and what goes into them.
There is no time to waste. The life sciences industry does not have the luxury of waiting for all of the stars to align before they take action. With agreed standardized data to define medicines, time to market for medicines and vaccine will accelerate and patient outcomes will improve.
Author Biography
Frits Stulp is Managing Director of Iperion Life Sciences Consultancy, and a prominent mover in IDMP circles. He was Program Manager of the fi rst completed IDMP implementation program and is a member of the EMA ISO IDMP Task Force. [email protected], www.iperion.com