A data gap analysis compares the studies and documents an applicant already holds against CIB&RC's data requirements for the chosen registration route, lists what is missing or unacceptable, and sets out how and when each gap can be closed.
What does a gap analysis deliver?
- A line-by-line comparison with the applicable guideline
- Studies that are missing, outdated or not acceptable
- Options for each gap: new study, supplier data, or waiver justification where permitted
- A timeline and the permits needed to do the work
When should it be done?
Before a 9(3) or 9(4) application, before adding label claims, and whenever you plan to rely on a supplier's data package.