Overview
New initiative Priority Review Update Verification Route
Pg 32
Priority Review
Background
First-in first-out queue system for evaluation of drug applications Three evaluation routes: 1. Full 2. Abridged 3. Verification
Evaluation Routes
No prior approval by any drug regulatory agency
Full
Abridged
Priority Review
A designation system that allows an application to be moved to the front of the evaluation queue i.e. it allows an application to bypass the queuing system
Evaluation Routes
No prior approval by any drug regulatory agency
Full
Abridged
Qualifying Criteria
The drug is intended for a serious lifethreatening condition, and The drug demonstrates potential to address a local unmet medical need
Definition
Unmet medical need
Absence of treatment option; or Lack of safe and effective alternative, and the drug would be a significant improvement compared to available alternatives, as demonstrated by a) Evidence of increased effectiveness in treatment, prevention, or diagnosis; or b) Elimination/substantial reduction of treatmentlimiting adverse drug reactions
Justification
1.
2.
Justification
3.
4.
How is the drug going to address the identified unmet medical need?
Extent to which the product is expected to have a major impact on medical practice, its major benefit, and unmet medical needs can be addressed
Justification
5.
Ultimately, we want to
Facilitate timely access to effective drug treatment for serious lifethreatening diseases where there is an unmet medical need Ensure a fair evaluation queue system and avoid any unjustified queue jumping
Verification Route
Background
Streamline the eligibility criteria, timeline & documentary requirements for verification route Widen the scope to allow greater flexibility and effective use of this route Enhance clarity and minimize inconsistency
Current approach
No. of RA# approvals 2 RAs Clinical & Quality Clinical only 1 RA* Clinical & Quality Clinical only
#
MAV-1
60 WDs
90 WDs
Reference agencies: EMEA, US FDA, Health Canada, MHRA, TGA * TGA as sole reference agency
Key updates
Pg 10,33,55
Approval by at least two reference agencies to ensure consistency in regulatory decision Eligibility extends to MAV-1 applications for biologic drugs Standard processing timeline: 60 working days (see appendix 1) Require both clinical & quality assessment reports to enable effective verification process
Streamlined approach
2 RAs# approvals Clinical & Quality reports NDA 60 WDs MAV-1 60 WDs
To facilitate applicants to obtain unredacted reports from FDA for submission via verification route:
Applicant may submit request for unredacted reports through HSA Request to be submitted in a prescribed format Sponsor authorization form available upon request Reports to be sent directly to HSA in 4-6 weeks (possible to raise request at pre-submission meeting prior to actual submission)
Other clarification
Assessment report should include all annexes and Q&As Quality dossier should include:
Initial dossier submitted to the primary reference agency All reports and/or documents pertaining to post-approval variations approved by the primary reference agency
Ultimately, we want to
Optimize the use of this route Facilitate application submission Enhance evaluation efficiency
Thank You