Becoming ‘IDMP ready’ is a marathon, not a sprint: the most important factor for compliance is being on the right path. So what’s your starting point?
For those who are tired of hearing about the accelerating approach of Identification of Medicinal Products (IDMP) in the European Union (EU), and all the associated changes that are required, here’s a fresh line of thinking.
There are two important truths to take forward.
- One, after all the theorizing and scaremongering, IDMP is suddenly real (in Europe, at least).
- Two, this is not a one-time undertaking: compliance will be a staged, iterative affair as requirements evolve – and should be approached as such.
The more important consideration, then, is whether your organization is on the right path to ensure long-term alignment with the demands of IDMP. And for each company, the starting point will differ.
What is your regulatory information management starting point?
Here are some of the most common scenarios pharma companies will typically be starting from, exploring the options in each case.
Scenario 1: No formal regulatory information management (RIM) system currently in place
Companies that are still managing the bulk of their regulated product information using spreadsheets – perhaps because of their modest size – will come unstuck in an IDMP data-driven world.
These organizations will need to start looking for a solution which, even if it doesn’t have full IDMP provision right now, provides a clear path to compliance (in other words, the vendor has a clear vision and roadmap for IDMP linked to its RIM offering).
Scenario 2: Existing RIM investment
Larger pharma companies which have already deployed a RIM system will need to assess to what extent IDMP features in their software vendor’s plans.
An evolving RIM solution may well have IDMP on its near horizon, enabling the organization to minimize disruption and maximize the return on its existing investment by upgrading to next-generation product releases.
On the other hand, if up to now the existing supplier has been slow to fulfil pledges to introduce eCTD publishing options, xEVMPD provision, analytics, or gateways to regulatory authority portals, it will be prudent to press them for plans for delivering IDMP capabilities. If the response isn’t satisfactory, it may be time to consider an alternative RIM supplier with futureproofing built more tangibly into its approach.
Scenario 3: An appetite for best-of-breed applications
For a long time now the life sciences software industry has advocated developing a ‘single source of truth’ for regulated product information – a master source that can be relied upon across multiple operational functions and content use cases.
But this shouldn’t mean that pharma companies have to pick a single vendor’s software to deliver everything. As life sciences moves to a data-driven, IDMP-based approach to regulatory process management and product look-up, companies would be effectively entrusting all of their medicinal product intelligence to a single software provider – creating a single point of vulnerability and risk.
A more sustainable and less exposed approach could be to standardize on an open-standards based infrastructure or platform which supports connectivity and data exchange with function-specific applications, via APIs.
So, instead of having a single vendor for all aspects of RIM, companies might choose best-of-breed suppliers respectively for document management, for eCTD, for analytics, for IDMP, and so on.
There are pharma companies already taking this approach today, and it’s working very well for them. And it could well be the smarter move. After all, pharma brands wouldn’t source all their raw materials from a single manufacturer.
It’s important for life sciences companies to look more closely at the paths from each scenario and discuss low-risk/minimal-cost options for developing an IDMP proof-of-concept alongside companies’ existing RIM set-ups, to test how expandable their current situations are and which IDMP option is likely to fit best.
Global Strategic Accounts Consultant
About the author
As Global Strategic Accounts Consultant at Amplexor Life Sciences, based in the UK, Ian Crone is responsible for understanding client challenges and working alongside customers to identify optimum global solutions - a role involving international travel and long-term customer engagement. His background is in chemical engineering – the subject of both his university degree at Strathclyde University in Scotland and the first 14 years of his career, at Unilever. Over the two decades since, Ian has been involved in the chemical and pharmaceutical industry, from every angle of drug development, for the biggest names in life sciences. He has been involved both from an industry and technology supply side, in roles at Oxford Instruments, BioStorage Technologies and Samarind. Before joining Amplexor, Ian spent a decade at biotech advisory firm IAC Global Consultants, helping biotech companies build bridges with large pharmaceutical and chemical companies.