Achieving regulatory excellence depends on a combination of optimisation processes, effective global systems, high data quality, and enhanced affiliate collaboration. However, transforming information management at a local affiliate level has been a challenge. Steve Gens reveals the findings of Gens & Associates research that has identified a persistent disconnect between central Regulatory and the local affiliate RIM data management experience.

Most life sciences companies have made global regulatory information management (RIM) system and process adoption a strategic priority, and improving affiliate engagement is paramount to achieving this goal. That’s because the overall aim is to create a high-performing regulatory organisation with high data quality, end-to-end, which the company can rely on and use as the basis for increasingly strategic decisions.

Ultimately, achieving Regulatory excellence depends on a combination of process optimisation, effective global systems, high data quality, and enhanced affiliate collaboration. One weak link in that chain could risk compromising all of the other efforts and investment.

However, transforming information management at a local affiliate level – across this last (or arguably first) mile of the internal regulatory matrix – has been notoriously challenging up to now. Highly manual processes, specific local market requirements, tool usage inconsistencies, as well as the obvious barrier of language differences, have often meant a gap in information visibility globally which adds risk to key regulatory processes.

RIM at the local affiliate

It’s a subject I raised afresh at Amplexor’s annual global BE THE EXPERT conference in the Czech Republic this summer, as a prelude to the publication of important new research which Gens & Associates has conducted into the state of RIM at the local affiliate level. These very latest findings, now in the final analysis, constitute the most comprehensive available globally to date on the evolving role and importance of local affiliates in efforts to make global regulatory processes more dynamic and efficient.

So, what’s the picture that’s emerging?

We first began tracking affiliate developments at Gens & Associates over eight years ago, as part of our broader Global World-Class RIM research. Our initial baseline picture of affiliate information management was informed by respondents from 74 countries, across several large multi-nationals, in 2015. The timing of that early study coincided with the initial push by many large multi-nationals and mid-tier life sciences organizations towards a simplified global system footprint, supported by standard global ways of working.

In terms of affiliate activity at that time, around 87% of local affiliates were recording and managing regulatory information in Excel, SharePoint and other local file shares – compared to just 13% who were doing this in a global system. So how much has changed since those early todays?

The 2023 study, launched back in May, is much greater in scope than our earlier investigations, including responses from over 320 local offices – from a pool of 20 sponsor companies each with 10 to 25 contributing affiliates of different sizes and geographic locations. This time we sought to build a more rounded global picture of the role of local affiliates in the creation and maintenance of all this vital regulatory information that global companies are working so hard to bring under control. To what extent is there now more fluid collaboration between central and regional operations, we wanted to know for instance.

Crucially, we designed the current study in partnership with industry, and with some of the key regulatory providers, to ensure the ability to test anecdotal observations on a more scientific/statistically-relevant basis.

The primary study goal has been to understand how core regulatory information is created, managed, consumed, and archived to support Regulatory activities from the Affiliate perspective. To this end, the survey spans specific Regulatory processes/activities – those around managing Submission Forecast and Planning; Product Registration Management; Health Authority Commitment Management; Health Authority Interactions Management; Local Label Management; Submission Content Management; Submission Archiving; Regulatory Intelligence Management; and Promotional Material, through the use of systems and tools.

Still a dearth of global, authoritative systems

From our initial deep-dive into the 2023 findings, we’ve distilled the following insights which confirm  there is still more work to be done in closing the global Regulatory information loop.

The study found that 53% of the time that affiliates spend on managing their Regulatory processes (as listed above) continues to involve use of local and regional tools, rather than global, authoritative systems. Even with this complexity 72% said their regulatory processes were efficient, yet only 65% felt their systems were easy to use. Where almost 7 in 10 survey (68%) of respondents felt that recent system and process investments had improved their situation, almost a third felt the opposite.

One of the largest findings was that the affiliates themselves are feeling the pain of the disconnection, expressing a strong desire to be more integrally included in global Regulatory capability process design, resource planning, system enhancement prioritisation, and overall governance by a wide margin.

Concerningly, only just (41%) of respondents expressed high confidence in the quality of data in their global regulatory systems; a further 43% had moderate confidence, indicating that there some level of verification needs to occur before they feel fully comfortable trusting and using the data.

System integration high on the wishlist

While most affiliates suggested that they were satisfied with the functionality of their global system, a strong need was expressed to have more seamless connections between the various different systems or modules within a platform so that there is “one place to go”. System integration/an improved interface and better training were key ‘wish-list’ items indicated by many respondents. To a large degree, the affiliates’ and central Regulatory teams’ perspective on RIM capability efficiencies were generally well aligned.

It does appear, as we suspected might be the case, that a certain disconnect persists between central Regulatory and the local affiliate RIM data management experience; that the affiliates’ experience isn’t as seamless, intuitive and rewarding as it might be and that workarounds are still getting in the way of reliable first-time data exchange and ongoing information transparency.

There is still work to do to uncover how affiliates feel they might be better supported and to identify remaining barriers to their collaboration and engagement with headquarters. To support this work, we will be conducting further analyses by size of company and geography. For instance, we will carry out and publish on our website regional comparisons looking at how Asia-Pacific markets are doing versus the Americas, or in comparison to Europe and the Middle East/Africa.

Without real-time local regulatory information and regulatory intelligence (the input needed for global dossier management), the efficacy of global RIM capabilities will continue to be compromised to at least some degree. Our analysis will provide some of the tools to address this.


About the author

Steve Gens is the managing partner of Gens & Associates, a global life sciences consulting firm specialising in strategic planning, RIM program development, industry benchmarking, and organisational performance.

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