T-37: Regulatory Review Reliance Models: What are the Barriers and Enablers to the Successful use of These Models for Medicines?
Poster Presenter
Neil McAuslane
Director
Centre for Innovation in Regulatory Science (CIRS) United Kingdom
Objectives
To identify what are perceived by agencies as opportunities, barriers and enablers to adopting reliance models as part of their regulatory strengthening initiatives and what needs to be considered by regulatory agencies to practically implement these risk based strategies for the review of medicines
Method
Discussions from two Workshops focusing on how to leverage and enhance the use of reliance models, held in Brazil (2017) and South Africa (2018), have been analyzed. 27 (11) agencies from South/ North America, Europe, Asia and Africa and 21 (15) companies were represented at one or (both) meetings.
Results
The summary results from the analysis of the workshop discussions have been split into three main areas - opportunities, barriers and enablers.
Opportunities in adoption of risk-based or reliance reviews include: High-quality and timely decision making; faster patient access to medicines; best use of agency resources; development of a collaborative environment between regulators; improved knowledge and expertise. It was also identified that there are opportunities to apply reliance approaches in other areas such as inspections, post-approval changes, and generics
Barriers to adoption of risk based or reliance models were seen as: ensuring such reliance approaches can be contextualised within the agencies national setting to ensure they are delivering their legal and organisational remit; which type of reliance model should be adopted and for which type of decision and for which products, (e.g. new medicine versus generic, post approval changes); what and how do the agencies actually review in regard to quality, safety and efficacy; and how to change the reviewers mindset. Trust between the agency and the agency to be referenced, how this is established was identified along with which reports (redacted or un-redacted) and data that should be made available from the different reference agencies, and the timelines for their availability was also discussed as barriers.
Enablers for the adoption by agencies for reliance models were identified from the group discussions: these included the ongoing convergence between agencies through their adoption of good review practices; the harmonisation of ICH technical guidelines; and active engagement by agencies in training and capacity building programmes in the development and regulation of medicine. It is also key that any reliance models put in place ensures the ability of authorities to continue to make their own informed decisions to protect public health.
Conclusion
Based on the analysis of the discussions from these meetings it is clear that many agencies and sponsor companies are interested in risk-based evaluations and would like to understand when and how they could or should practically implement a reliance model within their jurisdiction. However a number of questions for agencies considering adopting these routes need to be answered; what does this look like in reality; what are the areas the agency should evaluate specifically and in what depth; how to ensure reviewers approaches do not diminish the review quality or level of scrutiny; how much should the agency rely/ trust the reference agency and what detailed information do agencies need from the reference agency?
These could be answered through better dialogue between stakeholders who already use reliance models and those considering, and training initiatives for reviewers. The workshop discussions also identified future activities which would provide an evidence base for agencies to practically implement reliance models into their regulatory toolkit based on a framework developed from activities such as:
• Development of criteria or model for the elements of trust contained within current systems
• Clarification of the elements that make up a reliance review in particular, what agencies currently evaluate when performing a reliance review and what is needed in terms of reference agencies assessment reports.
• Provision of information, case studies or publications on all the reliance models that exist including implementation models or roadmaps so that agencies can select options suitable for their context based on workload and or regulatory capacity and capability
• Establish baseline indicators and periodically reassess after implementation of reliance based models to assess effectiveness
• Develop tools and guidance on good reliance practices to facilitate use of reliance or risk-based approaches
Additional Authors: Dr M Bujar, P Patel, Dr L Liberti
