Question 11 of 20 Intermediate Concept
How do FDA expedited programs compare with PRIME and conditional marketing authorisation in the EU?
Short answer
FDA has four tools for serious conditions: fast track, breakthrough therapy, accelerated approval and priority review. The EU's nearest equivalents are PRIME for early support, accelerated assessment for a shorter review, and conditional marketing authorisation for approval on less complete data. They overlap in purpose but differ in criteria and legal effect.
Why
FDA's 2014 guidance on expedited programs explains each tool. Fast track and breakthrough therapy are designations during development that bring more interaction and rolling review. Breakthrough needs preliminary clinical evidence of substantial improvement over available therapy.
FDA responds to both requests within 60 days. Accelerated approval is an approval pathway based on a surrogate or intermediate endpoint reasonably likely to predict benefit, with confirmatory trials required. Priority review shortens the review goal to 6 months instead of 10.
In the EU, PRIME gives early dialogue for medicines that may address an unmet need to a significant extent, and products in PRIME can expect to be eligible for accelerated assessment, which cuts active review from 210 to 150 days. Conditional marketing authorisation lets the CHMP recommend approval on less comprehensive data for serious diseases when the benefit of immediate availability outweighs the risk of missing data. It is valid for one year, renewable, with specific obligations.
A drug can be breakthrough in the US and refused PRIME in the EU, because the criteria and evidence bars differ.
A strong answer covers
- Designations versus approval pathways
- Breakthrough criterion of substantial improvement
- Priority review 6 months versus 10 months
- PRIME, accelerated assessment 150 days, conditional MA
- Conditional MA valid one year with specific obligations
Common mistakes
- Treating breakthrough designation as a form of approval.
- Equating PRIME with conditional marketing authorisation.
- Assuming a US designation guarantees the equivalent status in the EU.
The interviewer might ask next
Which confirmatory evidence would you plan before seeking accelerated approval?