Successful medicine development results from the ability to effectively navigate regulatory, HTA, and payer pathways throughout a product’s lifecycle.
As the global development environment becomes more complex, the need to understand the confluence of these pathways has become a driver of the medicines development process. And as these processes evolve and transform in response to changing local, regional and global influences, it becomes increasing difficult to monitor and comply with the development routes to be followed within each jurisdiction. Answering simple questions about each agency’s responsibilities can be time consuming and confusing. Furthermore, conducting true head-to-head comparisons of these pathways among countries has been virtually impossible with existing resources.
See the big picture in small detail
Now there is a simple, yet comprehensive way to view the approval and reimbursement pathways in jurisdictions all around the world in a single, up-to-date compendium. Over the past 12 years, CIRS – the Centre for Innovation in Regulatory Science, has collaborated with more than 75 regulatory and payer agencies to understand the nature of their activities.
Using our proprietary methodology to map regulatory, HTA and payer pathways and to illustrate the core functions of each agency, CIRS has developed a simple, globally recognised approach to understanding this diverse landscape.
More than just maps
- Embedded hyperlinks point to current information for each agency
- Graphical icons provide simple visual clues to each agency’s specific roles and activities
- “Sticky notes” function on web lets you annotate your password-protected maps based on your needs and goals
- “Compare” function permits side-by-side comparisons of up to four jurisdictions
Sample Map: Netherlands
Use the CIRS Regulatory and Reimbursement Atlas™ to:
- Determine the sequence of interactions with agencies in each jurisdiction, while understanding each agency’s particular functions
- Plan your development strategy by identifying potentially rate-limiting process steps
- Compare processes between jurisdictions to facilitate simultaneous development programmes
- Train staff on the requirements for medicine development in specific countries; inform work colleagues of intricacies of each jurisdiction’s access processes