An increasing number of National Regulatory Authorities (NRAs) are turning to reliance as a way to conserve resources, build expertise and capacity, increase the quality of their regulatory decisions, reduce duplication and, ultimately, promote timely access to safe, effective and quality products. Reliance encompasses a wide range of regulatory approaches and practices involving two or more NRAs (including work sharing) and can be applied to many aspects of regulatory oversight across the medical product life cycle. This includes marketing authorisation, pharmacovigilance, inspections, quality testing, clinical trials oversight and post-approval changes.
As the concept of reliance is still relatively new, companies and NRAs may have limited experience in using it to register new medicines. To help improve understanding of the return on investment (ROI) for using reliance pathways, CIRS carried out a perception survey of its company members in September 2020. The results, which are presented here in this Briefing, are not only useful for companies but also for NRAs as they look to identify the barriers to using their reliance pathways and areas for improvement.
If you have any questions or comments on this Briefing, please don’t hesitate to get in touch with Jenny Sharpe: firstname.lastname@example.org