Cluster | Core considerations |
Stakeholders and target mapping | Landscape assessment Who are the regulatory bodies in target markets, and for which remits and geographical jurisdictions (national, regional, etc.) are they responsible? |
Stakeholder decision drivers | Priorities/awareness Which diseases and unmet needs do regulators prioritise? Do they prefer specific types of interventions for an indication? |
Need/preferences (value-fit) Which are the most meaningful safety and efficacy data in general (across regulators) and specifically (per regulator, e.g. data on domestic cohorts)? How can data collection be streamlined for requirements across regulators? E.g. by international trialling of intervention(s) in various domestic cohorts. Does own product conflict with other treatments? Are new methods of demonstrating safety/efficacy accepted (e.g. in silico modelling)? Are regulatory data requirements pre-determined by previous competitor applications (and approvals)? | |
Application/indications/label (decision points) Which are the likely indications at initial approval; which is the “cleanest” label possible? Which resource consumption (type and quantity of efficacy/safety data) will likely lead to a less or more restricted label (forecasting)? Which likely impact will different TPPs/labels have on uptake? Are providers using product out of indication and does data support the application for indication extension? Might post-launch data collection commitments change basis for cost assessment? Feeds into HTA for payers in next section. Are future changes to regulations (e.g. new hurdles) likely due to externalities and competitor products? | |
Stakeholder engagement | Engagement/relationship Has the value fit of TPP been tested and validated with stakeholders in market (e.g. does intervention really address unmet need or improve outcomes)? A TPP “endorsed” by physicians can considerably improve negotiations with regulators. |