01_Priority Review and Verification Route


Priority Review & Verification Route

Agnes ChanSenior Regulatory Specialist

Pharmaceuticals & Biologics BranchTherapeutics Products Division

Health Products Regulation GroupHealth Sciences Authority


Overview

• New initiativePriority Review

• UpdateVerification Route


Priority Review

Pg 32


Background

• “First-in first-out” queue system for evaluation of drug applications

• Three evaluation routes:

1. Full2. Abridged3. Verification


Evaluation Routes

Approved by one drug regulatory agency

Verification based on fullassessment report by reference regulatory agency.

Full

Abridged

VerificationApproved by two reference agencies

No prior approval by any drug regulatory agency

Timeline: 60 working days

Full quality, non-clinical, & clinical data.


Full quality data and Phase II & III clinical data. Timeline: 180

working days


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

Approved by one drug regulatory agency

Verification based on fullassessment report by reference regulatory agency.

Full

Abridged

VerificationApproved by two reference agencies

No prior approval by any drug regulatory agency


Full quality, non-clinical, & clinical data.


Full quality data and Phase II & III clinical data. Timeline: 180

working days


Qualifying Criteria

• The drug is intended for a serious life-threatening 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 treatment-limiting adverse drug reactions


Local public health concerns

Disease conditions include:• Cancers

• Infectious diseases: Dengue, tuberculosis, hepatitis, malaria


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


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


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


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


Ultimately, we want to…

• Facilitate timely access to effective drug treatment for serious life-threatening 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

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

90 WDs90 WDs120 WDs

1 RA*• Clinical & Quality• Clinical only

60 WDs60 WDs90 WDs

2 RAs• Clinical & Quality• Clinical only

MAV-1NDANo. of RA# approvals


Key updates• 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

Pg 10,33,55


Streamlined approach

60 WDs60 WDs• Clinical & Quality reports

MAV-1NDA2 RAs# approvals

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


• To facilitate applicants to obtain unredactedreports from FDA for submission via verification route:

Applicant may submit request for unredactedreports through HSARequest to be submitted in a prescribed formatSponsor authorization form available upon requestReports 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 agencyAll 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

01_Priority Review and Verification Route

Documents

Transcript of 01_Priority Review and Verification Route