New research has confirmed that incountry Life Sciences company affiliates feel unrepresented in the pursuit of streamlined regulatory information management on a global scale. In the light of this, central organisations must determine how to increase participation in efforts to improve global RIM design, to maximise efficiency for everyone and to drive a tangible return from nowsizeable RIM investments. Steve Gens of Gens & Associates analyses the findings.
Regulatory excellence in Life Sciences companies 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 the other efforts and investment. Yet, in too many cases, highly manual processes, specific local market requirements, and inconsistent use of tools have left a gap in global information visibility for pharma organisations of all sizes.
This oversight is adding risk to key regulatory processes and undermining the potential return on investment in regulatory information management systems (RIM) – the subject of extensive spending over the last 15 years across the industry. The role of affiliates, and their contribution to RIM success (or not), has been the subject of important new research we have just published at Gens & Associates. It is the most comprehensive available study performed to date, which explores the evolving role and importance of local affiliates, in efforts to make global regulatory processes more dynamic consistent and effective through optimised systems and tools. Such processes include submission forecasting and planning; product registration management; health authority interactions and commitment management; local label management; submission content management, and archiving; regulatory intelligence management; and promotional material management.
Progress is Evident, but More Work is Needed
Our latest research includes detailed feedback from 320 local offices/affiliates representing 94 countries. The affiliates represented 20 sponsor companies, most of which yielded between 10 to 25 affiliates of varying size and geographic location to participate in the research. Although this is the first time, we have investigated the affiliate perspective in such detail, we have been charting various aspects of affiliate operations in managing regulatory information as part of our World Class RIM study program for around a decade.
This has enabled us to compare the current findings with a baseline, and we have determined that companies are now roughly halfway to achieving a strong level of operating performance from a local affiliate perspective. For example, many companies are striving to reduce the time from first market to last market regulatory submission by 50% (cutting 9–12 months from this critical cycle). As things stand, 52% of the time spent by affiliates on managing their regulatory processes continues to involve use of local and regional tools, in addition to or instead of global, authoritative systems. The remaining 48% of time is now used in centrally designated platforms which is encouraging, and represents a significant improvement on the 13% reporting the same back in 2015. Clearly, there is still work to be done to further streamline operations.