Category 3: Managing Guidance and Requirements from Health Authorities

Globally, inspectors within health authorities have differing opinions on RBM and may set different expectations during inspections. We hope to see alignment across agencies in order to prevent the creation of complex and country-specific RBM processes. Further, cross-agency alignment will increase compliance while reducing fears around inspection findings and rejection of application, since interaction with RBM will be more systemized.

Further, there is an International Council for Harmonisation of Technical Requirements for Human Use (ICH) E6 guide that will be published in the future and which may encourage companies to implement RBM over time.

More clarity is needed on RBM documentation requirements; right now it is unclear which RBM activities and information (e.g., issues, actions, remote data reviews) should be documented where (e.g., in reports, Trial Master File). We predict that in coming years, as RBM implementation becomes more commonplace, we’ll see external communication and accessible knowledge banks when filing with health authorities.

RBM focuses on errors that matter, not error-free research. We hope to see this key differentiator emphasized and supported by agencies. Some agencies, such as the US Food & Drug Administration (FDA) and the UK’s Medicines and Healthcare Products Regulatory (MHRA), have released guidance on RBM – reflecting that they actively support the model and are taking actions to establish RBM training for inspectors. Still, there is ample work needed to get additional health authorities on board, as well as establish a more RBM-friendly and consistent training.

As regulatory guidance evolves and becomes increasingly prescriptive around RBM, a natural outcome will be the adoption and increased use of RBM and Centralized monitoring activities.