EMA’s IDMP-based medicines database: where are we now?
SummaryIf standardised medicinal product data is to be of tangible real-world benefit, it’s vital that momentum around IDMP is not lost in 2020, warns Iperion’s Remco Munnik
- Author Company: Iperion
- Author Name: Remco Munnik
- Author Email: Remco.firstname.lastname@example.org
Substantial investment has gone into the preparations for the EU’s implementation of the ISO IDMP (identification of medicinal products) standards, which must not be compromised in 2020 - whatever the current hold-ups with European Medicines Agency’s IDMP implementation guidelines, and despite the new Veterinary Regulation vying for attention.
The goal of IDMP is to create a current central data repository of medicinal products that can be readily searched, understood and relied upon internationally. SPOR (Substance, Product, Organisation and Referential) data management services are the key to enabling this, paving the way for meaningful data-sharing across departmental, organisational and geographical borders. This is so data can support a range of different use cases - supported by a Target Operating Model that will assess data during the regulatory process to ensure data quality and consistency, and optimise the exchange of application data between regulators and applicants.
With implementation so close, it is now that the really interesting and exciting work should begin; that real-world use cases should proliferate in pilot form, reminding everyone of IDMP’s wider potential. But this will require the proactive input of all stakeholders in 2020.
Data must overtake documents as master content
While the explicit aim of IDMP is to capture complete, high-quality product data sets as regulatory documents are submitted, it is not yet clear how that data will be validated and used.
It doesn’t help that, between the pharmaceutical companies, the NCAs, EMA and the wider industry, there isn’t one single party with overall accountability for the IDMP database and its usage. Yet, just as the SPOR Task Force leadership is made up of three co-chairs (EMA, NCA and industry), so each stakeholder group must assume a role in forming and delivering the bigger picture.
In one significantly encouraging development, Joris Kampmeijer, CIO of Dutch regulatory agency MEB and NCA co-chair of the EU’s IDMP SPOR Task Force, has pledged to lead the way in cooperation with EMA and Industry. Imminent plans include the roll-out of new test cases. One will be a proof-of-concept (PoC) for administrative data exchange in scenarios where there is a company name change. It will show how, via a single portal accessible by all stakeholders, a data-driven change to details could alleviate duplication of effort as updates are reflected promptly across all records.
Other work-streams will look at how unique signature fields to identify substances internationally could transform the ability to pinpoint and take action if new safety findings are reported. A further project will look at the potential impact of linking the EMA’s IDMP database with the existing drug serialisation database which is designed to ensure that medicines cannot be falsified. Integration between the two resources could make it easier to spot relative product shortages versus availability between different EU markets.
Projects like this are crucial to maintaining broad industry engagement, because they focus attention on what’s possible, and on what needs to be done to deliver such innovation.
Everyone has an active role to play
As 2020 finds its stride, there needs to be a more concerted effort to promote and realise IDMP’s broader potential, and everyone must play their part, setting aside time, budget and skilled personnel to explore what’s possible, and ideally getting involved with or driving new PoC projects.
A broader range of stakeholders should seek representation on influential committees, too – such as the EU Telematics management board. In the meantime, Heads of Medicines Agencies (HMA) and EMA should look to set some firm deadlines by which drug approval based on the submission, assessment and approval of data becomes the standard process.
Behind many of the hoped-for achievements lie SPOR data management services - with good data quality/a strong target operating model – which will essential to capitalise on IDMP’s potential. So, above all, this should be the focus for 2020.
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, and as such strongly committed to contributing to the actual implementation of the ISO IDMP standards.