Regulatory workloads in the pharmaceutical sector are increasingly outpacing company growth, prompting a significant shift towards AI-enhanced regulatory process automation. A recent survey conducted by Censuswide, involving 100 senior regulatory professionals from US pharmaceutical and biopharmaceutical organisations, indicates that these professionals are facing escalating regulatory obligations that they believe will continue to surge in the coming years.
The survey found that approximately 60% of respondents acknowledged that the increase in regulatory responsibilities has been substantially greater than the normal growth experienced within their organisations over the past five years. Among the various challenges identified, participants highlighted a number of inefficiencies, including excessive time spent on producing submissions and dossiers, maintaining labelling compliance, and verifying the correctness and completeness of submissions. Additional barriers impacting efficiency include handling agency queries, existing IT system inadequacies, and considerable time lost to data quality checks.
Interestingly, the survey revealed that concerns related to a lack of qualified personnel were less prevalent among the respondents. Instead, the consensus appears to be that pharmaceutical companies are now looking to leverage technological advancements to streamline regulatory processes. The findings pointed to a growing interest in AI, with 35% of participants currently utilising some form of artificial intelligence in their regulatory practices, and an additional 42% planning to invest in AI within the next 18 months.
Despite this enthusiasm, some respondents expressed reservations regarding AI's implementation within the regulatory landscape. Common barriers cited included outdated IT infrastructure (45%), perceived risks of investment outweighing potential benefits (44%), and the inconsistent availability of quality data (42%). Furthermore, a significant 39% of respondents deemed the technology as being too immature or unproven, while 16% voiced distrust in AI's capabilities. Budget limitations were considered a minor hurdle, with only 15% highlighting budget constraints as an issue.
The survey also explored factors that might encourage companies to transition from interest in AI to active investment. Notably, 41% of respondents indicated that competitive pressure, knowing that peers are adopting AI technologies, would spur them to invest. Continued resource pressures (40%) and advancements in AI technology itself (36%) were also significant motivators. Additionally, respondents pointed to the availability of specific AI tools aimed at addressing their regulatory challenges (35%) and the increasing affordability and ease of deploying relevant IT systems (33%) as critical factors in making investment decisions.
As for the long-term outlook on AI within regulatory settings, almost half (48%) of the respondents expressed the belief that AI would significantly transform routine regulatory tasks, thereby streamlining processes. Furthermore, 43% felt that AI could enhance the accuracy and quality of information provided to regulators and patients alike. A substantial proportion (39%) noted that AI would be essential for regulatory functions to keep pace with growing market demands, with 35% anticipating substantial time and cost savings as a result of AI implementation.
These results highlight not only the pressing challenges faced by regulatory professionals in the pharmaceutical sector but also the potential transformative impacts of AI technology on regulatory workflows. As companies navigate the complexities of regulatory compliance, clear strategies for integrating AI capabilities are anticipated to play a critical role in optimising efficiency and efficacy in their operations.
Source: Noah Wire Services