Spring Intro 2023

30/03/2023

Accelerated Assessment

For medicines expected to be of major public health interest • Justify unmet medical need • Demonstrate that the product address this unmet need • Provide strength of evidence to support fulfilling unmet need

Can shorten MAA review timeframe from 210 to 150 days • Initial assessment in 90 days instead of 120 days (preliminary report Day 60) • Only 1 month clockstop to address assessment questions • No additional clockstop during procedure • no additional month to address List of Outstanding Issues • Most likely CHMP opinion after 150 days Application process • Discuss proposal at pre-submission meeting with EMA • Strongly recommended 6/7 months in advance of MAA submission • Official request to be submitted 2/3 months in advance of MAA submission using defined timetable

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/accelerated-assessment

The Organisation for Professionals in Regulatory Affairs

71

US Priority Review

Program

Criteria

When to Submit

Features/Considerations

Serious condition AND significant improvement in safety and effectiveness, OR

With original BLA, NDA, or efficacy supplement

Shorter review clock for marketing application (8 months vs. 12-month standard review under PDUFA V)

•

•

Priority Review

Pediatric study under 505A, OR

•

(designation)

QIDP, OR

•

Priority review voucher

•

The Organisation for Professionals in Regulatory Affairs

72