IDMP data standards – spotlight on 2021

Amid the disruption of 2020, there has been huge emphasis on healthcare and the role of the pharma organisations, marketing authorisation applicants and holders (MAAs and MAHs), and of regulators, in a crisis. Speed to market (bringing relevant medicinal products, for example new vaccines, to market swiftly), yet also thoroughness in safety and quality assessments, have become paramount and visible to a much greater degree in society.

Countries, governments, health care providers, entire societies are crying out for approved medicinal products, but no one can afford for standards and requirements to be compromised in the rush to deliver what’s needed. In fact, Covid-19 has shone a light onto the broader potential for global data standards, including those defined via ISO IDMP (Identification of Medicinal Products) which Europe is now so close to implementing via the EMA SPOR programme.

Over the last 12 months, the European Medicines Agency (EMA) completed its reorganisation and ‘futureproofing’ exercise and is now  committed to ensuring that any investments in the product data standards are reusable across a wide range of use cases – addressing critical everyday business processes.

This is significant. Up to now, EMA’s chief goals for IDMP have been to streamline the regulatory assessment and authorisation of medicinal products, and to support pharmacovigilance activities. Yet, if set up properly, standards-based master data about products could be used for all kinds of uses cases between industry and regulators – from clinical trial approvals and shortages management, to product serialisation and tracking.

All of these advances are building towards a stronger backbone and greater momentum behind IDMP, its rollout and its potential impact. This, combined with a growing awareness across all stakeholders of the value of high-quality reusable data in streamlining routine processes, is creating a new sense of purpose and urgency around the ISO standards .

Keeping pace with requirements

So, what can we expect in 2021, and what should pharma companies be doing now so that they keep pace with requirements - and put themselves in the best position to harness IDMP’s fullest potential?

Knowing that the model for submitting regulatory data within the regulatory processes - the so-called Target Operating Model (TOM) – will change, and that technology environments at EMA and NCAs will have to support this, the SPOR Task Force co-chairs have been working to set an optimum level of ambitions to allow positive forward movement. They have compromised on a two-step approach which works around any current limitations.

The first step has been to define electronic data submission for the centralised regulatory process only, via EMA’s Gateway and/or API. With fewer players involved initially, the initiative will be easier to 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 involving NCAs. In phase two, 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. T

This two-step process allows a ‘Europe of multiple speeds’ – the possibility that individual NCAs might each pick a different point at which to move to phase 2. To contain that risk, the various stakeholders are working to secure a commitment to a capped transition period, so that the two systems don’t run in parallel indefinitely.

Richer data to support patient outcomes

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. But where companies persist in seeing SPOR and IDMP as a burden to be endured, the next years will be painful and increasingly demanding. For many organisations, IDMP will have been seen up to now as just another secondary data set that has to be generated. 

A good way to bed in new thinking is to look for 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.

2021 will bring a sharper focus on the patient. With new, richer data sets as a backbone to their operations and an asset in support of primary business processes, pharma businesses will be in a great position to improve  patient outcomes whatever path the Covid crisis takes next.

About the author

Remco Munnik is Associate Director at Iperion, a globally-operating life sciences consultancy firm which is paving the way to digital healthcare, by supporting standardisation and ensuring the right technology, systems and processes are in place to enable insightful business decision-making and innovation.

Remco.munnik@iperion.com

www.iperion.com