A series of delays may have sapped momentum, but it was never in doubt that the European Medicines Agency would deliver ISO IDMP. Now, the first implementation guide is out for consultation, to be followed by a second actionable version by next year. And although life sciences firms will have a year to comply, getting everything in order will be a lot of work. Siniša Belina suggests some useful next steps.
Those life sciences firms that had put ISO IDMP (the global standard for Identification of Medicinal Products) on a backburner for the last one to two years, due to a series of false starts, now need to turn up the heat. Implementation guidelines are being finalised and the countdown to compliance has begun in earnest. Next stages should go beyond developing a vision and roadmap for delivering compliant submissions (as required by the European Medicines Agency from 2021), toward determining how firms will maximise their return on investment.
Surveying the readiness gap
Some larger multinationals now have proof-of-concept projects to build on – which others have a chance to learn from. In the most advanced scenarios, these companies are looking to the high-quality master data sets they are working towards as the basis for process automation, with the potential for substantial efficiency gains and risk reduction benefits. These are the organisations that took advantage of delays with IDMP’s rollout to map out wider internal applications for all of this rich data they are starting to collate about their products and processes.
But even these companies have not yet started to organise their master data. They may have formulated an optimum approach to data management, and identified stakeholders and teams who will own and deliver this, but the extensive groundwork that will be needed to locate all of the data, assess its completeness and quality, and establish mechanisms to fill in any gaps, is all still to do.
Smaller organisations that have taken a ‘wait and see’ approach until now could capitalise on this inertia to get ahead, borrowing the conclusions of those who’ve considered IDMP compliance considerations from all angles.
That includes the value of maximising the data assets companies must now build, by making sure they will be compiled in a readily reusable form. Certainly, waiting for IDMP-specific solutions to enter the market is not advisable. If these applications’ sole aim is compliance with EMA requirements, firms risk merely generating new data silos which add no value for the business.
Harnessing the broader intentions of IDMP – greater data quality, instant traceability etc – offers life sciences organisations so much more, providing the basis for improved end-to-end visibility across products and their lifecycle, transformation of global labelling and management of translations, and so much more.
Creating solid foundations for wider transformation
In advanced master data management scenarios, which AMPLEXOR has dubbed MDM 2.0, companies will be able to use definitive, centralised product information to transform the way teams create important, routine documents. Document authoring automation rates of 90%+ are quite possible, paving the way for a 10-fold acceleration in preparing regulatory submissions and patient-facing materials – reducing costs, and risk of error, while substantially improving speed to market.
Creating an IDMP strategy with master data at the centre involves investing in and building an agreed, single version of product truth with the potential to inform and be repurposed ad infinitum across multiple different use cases.
Then firms can start to work towards smarter document management, including structured authoring. Here, approved ‘fragments’ of content can be called up automatically and pulled into specific documents using smart templates, orchestrated by strict workflow rules that teams can control. In routine scenarios, it is quite possible than 100% of document compilation and preparation, in any designated language, could be automated. They can also start to add in complementary information (about country-specific requirements, or a product’s global status across its lifecycle) which will more directly serve internal business agendas and enable desirable process improvements.
Indeed, industry transparency initiatives such as ISO IDMP could trigger a new era of unprecedented data-based insights. Add artificial intelligence and powerful, large-scale data analytics into the mix, and it becomes easier and faster to search for new patterns and discoveries that might once have been impossible to detect. Where data is confined to static documents, or stored in one-dimensional formats, it is much harder to distil new insights from it. A fully-rounded, master data approach to product information unlocks its latent potential.
Beyond departmental boundaries
It pays to think about product profiles and data sets in the broadest possible terms, certainly. While IDMP encompasses clinical indications, and contraindications and adverse reactions, for instance, an MDM 2.0 approach to data preparations might also encompass CMC data, structuring more of this for re-use and more readily accessible insights. After all, manufacturing is where most changes happen across a product’s lifecycle, which will have a bearing on what needs to be reported, and what must be reflected in all of its labelling and patient information. So it makes sense that this fuller profile information is built into product databases, alongside clinical and patient safety data.
An extended approach to product data management could lead to accelerated and even automated CMC document creation (eg Module 3 documents), and the ability to more efficiently and reliably assess the impact of manufacturing changes on regulatory obligations, down to a country by country level. This in turn would help with resource planning, adding further operational benefits. Meanwhile translations could be packaged for processing simultaneously, using document auto-population with already-approved translated blocks of content.
A further benefit for companies that put in the groundwork now is that they will have a head start when other geographical regions, such as the USA, start to mandate IDMP-based requirements too. Certainly, more holistic data reporting and real-time product transparency is the way global market requirements are heading.
For now, the priority should be to get hold of the latest draft EMA implementation guidelines – so that companies can determine which data to focus on first, what format to follow, and how to structure their data. The sooner firms get started, the greater their opportunities to optimise ROI.
Siniša Belina is a Senior Life Sciences Consultant within AMPLEXOR Life Sciences Product Management team. www.amplexor.com