Current Edition

Beyond modernisation– Unlocking the Value
of Regulatory Information Management

Biopharmaceutical companies are now at an important inflexion point. Most have completed their modernisation of the Regulatory function globally, bringing improvements to efficiency, according to newly-published Gens & Associates research, the 2022 World Class RIM Survey. Founder Steve Gens reveals how respondents are planning to harness regulatory information management (RIM) as an enterprise asset.

It’s now 10 years since my company began tracking the ambitions of life science organisations around the world in relation to improving the management of regulatory information, through our World-Class RIM survey series. Our newly-published 2022 research confirms that, as we predicted, a majority of companies have now largely completed the foundational phase of their Regulatory function modernisation in which RIM becomes an important enterprise asset. Those leading the way have also begun to deepen the strategic partnership with other functions such as clinical, quality, and manufacturing – to improve regulatory pathways/expedite new product approvals in all markets; to ensure compliance for existing products; and to harness regulatory information management (RIM) as an enterprise asset. They also believe that further digitisation is required to fully unlock regulatory potential and contribution.

Next-level Process Optimisation

As others catch up, and as the leading transformers look to the next level for process optimisation and more, a whole new chapter is going to unfold. But what is the opportunity that lies ahead, and what specific plans are emerging? When we compare our very latest survey with previous ones, we see a number of clear trends. RIM-related investment is becoming more strategic and ‘outward looking’. As a critical mass of biopharmaceutical companies complete the groundwork of a process and system modernisation program that started in earnest in around 2013, they are shifting their focus toward organisational priorities, advanced technology, and cross-functional information sharing. Although a strategic priority, most organisations have yet to fully realise global RIM adoption, with just 32% claiming this in 2022 and another 54% still working towards this goal. Even with an increase in end-to-end process work and affiliate access to most global systems, there is a gap in the ability to deliver full-scale process transformation. For this to be possible, innovation is now needed at an affiliate level:

  • in the way that local regulatory intelligence is shared globally and integrated to the global dossier process, to reduce time to submission and health authority approval;

       • in resource allocation, via improved submission planning and forecasting, to better inform local teams to upcoming life cycle management submission (which typically accounts for 80% of portfolio work); and in improved control of the deviation process for label management, to ensure proper label management. Since the majority of local affiliates are infrequent users of RIM systems and processes, innovation promises to simplify complex regulatory activities requiring global coordination.