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Priority Review & Verification Route

Agnes Chan Senior Regulatory Specialist Pharmaceuticals & Biologics Branch Therapeutics Products Division Health Products Regulation Group Health Sciences Authority

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Overview
New initiative Priority Review Update Verification Route

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Pg 32

Priority Review

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Background
First-in first-out queue system for evaluation of drug applications Three evaluation routes: 1. Full 2. Abridged 3. Verification

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Evaluation Routes
No prior approval by any drug regulatory agency

Full

Full quality, non-clinical, & clinical data.

Timeline: 270 working days

Approved by one drug regulatory agency

Abridged

Full quality data and Phase II & III clinical data.

Timeline: 180 working days

Approved by two reference agencies

Verification based on full Verification assessment report by reference regulatory agency.

Timeline: 60 working days

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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

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Evaluation Routes
No prior approval by any drug regulatory agency

Full

Full quality, non-clinical, & clinical data.

Timeline: 270 working days

Approved by one drug regulatory agency

Abridged

Full quality data and Phase II & III clinical data.

Timeline: 180 working days

Approved by two reference agencies

Verification based on full Verification assessment report by reference regulatory agency.

Timeline: 60 working days

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Qualifying Criteria
The drug is intended for a serious lifethreatening condition, and The drug demonstrates potential to address a local unmet medical need

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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

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Local public health concerns

Disease conditions include:
Cancers Infectious diseases: Dengue, tuberculosis, hepatitis, malaria

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Justification
1.

How serious is the disease?

Seriousness of the disease condition, local & worldwide mortality rates, anticipated morbidity and debilitation as a consequence of the disease

2.

What is the clinical relevance in the local population?

Local epidemiology data & requests through named-patient exemption

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Justification
3.

Is there clinical evidence of unmet medical need?

Unmet needs, available treatment options and inadequacy of available therapies

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

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Justification
5.

What is the scientific basis?

The strength of evidence supporting the claims of addressing unmet needs, or, of significant improvement compared to available treatment

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Request for priority review

Written request with justification to be submitted at the point of filing of application Applicant will be informed of the outcome at the point of acceptance of application after screening

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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

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Verification Route

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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

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Current approach
No. of RA# approvals 2 RAs Clinical & Quality Clinical only 1 RA* Clinical & Quality Clinical only
#

NDA 60 WDs 90 WDs 90 WDs 120 WDs

MAV-1

60 WDs

90 WDs

Reference agencies: EMEA, US FDA, Health Canada, MHRA, TGA * TGA as sole reference agency

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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

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Streamlined approach
2 RAs# approvals Clinical & Quality reports NDA 60 WDs MAV-1 60 WDs

Reference agencies: EMEA, US FDA, Health Canada, MHRA, TGA

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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)

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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

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Ultimately, we want to
Optimize the use of this route Facilitate application submission Enhance evaluation efficiency

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Thank You

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