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Verification evaluation route for new drug application

Follow this guide on the NDA documentary requirements, fees and turnaround time when registering a therapeutic product via the verification evaluation route.

Eligibility

You can submit a NDA to register your therapeutic product via the verification evaluation route if it:

  • Has been approved by at least two of our reference drug regulatory agencies at the time of submission.
  • Has been approved within three years by the chosen primary reference agency.
  • Has a declaration letter by the product owner/applicant stating that all aspects of the product’s quality are identical to that currently approved by the primary reference agency. This includes the compulsory submission of the unredacted and unedited assessment reports and supporting documents from the chosen primary reference agency.
  • Does not need a more stringent assessment due to differences in local disease patterns or medical practices.
  • Has not been rejected, withdrawn or approved via appeal process or pending deferral by a drug regulatory agency for safety or efficacy reasons.
  • Is not a biological product.

NDA-3 applications

You may register the subsequent strength of a currently-registered therapeutic product as a NDA-3 via the verification evaluation route under one of the following conditions:

  • Has been evaluated and approved by only one of our reference drug regulatory agencies, the NDA-3 must be submitted within two years from the date of approval of that reference drug regulatory agency.
  • Has been evaluated and approved by at least two of our reference drug regulatory agencies, the NDA-3 must be submitted within three years from the date of approval by the chosen primary reference agency.

Note:

  • The proposed indication, dosing regimen, patient group, and direction for use must be identical to the corresponding approved NDA-1 and NDA-2 products.
  • The proposed PI/PIL are consistent with that currently approved for the corresponding NDA-1 and NDA-2 products.

Submission requirements

Application dossier requirements

You must submit the application dossier within 2 working days of the PRISM application and organise it in either an International Council for Harmonisation (ICH) Common Technical Document (CTD) or ASEAN CTD (ACTD) format. You need to submit all documents in English.

All administrative documents under Module 1 (ICH CTD) or Part I (ACTD) must be submitted in soft copy in PRISM.

The other parts of the ICH CTD or ACTD may be submitted online via PRISM or in a CD/DVD labelled with the following information:

  • PRISM application number.

  • PRISM submission date.

  • Product name.

  • Application type.

  • Contents of the CD/DVD (e.g. Module 2 and 5).

Documents

Location in ICH CTD

Location in ACTD

Required for NDA verification route

Administrative documents

Module 1

Part I

Yes

Common technical document overview and summaries

Module 2

Incorporated in Parts II, III and IV

Yes

Quality documents

Module 3

Part II

Yes

Non-clinical documents

Module 4

Part III

ICH CTD: No
ACTD: Overview only

Clinical documents

Module 5

Part IV

Study reports of pivotal studies and synopses of all studies


Documents from primary reference agency

For an application submitted under this route, you need to declare one of the reference drug regulatory agencies as the primary reference agency from which the qualifying supporting documents will be submitted. This includes the compulsory submission of the unredacted and unedited assessment reports and supporting documents from the chosen primary reference agency.

In the event that the primary reference drug regulatory agency did not approve the most stringent indications, dosing regimens, patient groups and/or directions of use, the clinical assessment report from the reference drug regulatory agency that approved the most stringent indications, dosing regimens, patient groups and/or directions of use should be submitted.

Primary reference agency Documentary requirements
  • Health Canada
  • USFDA
  • UK MHRA
  • EMA
  • Complete clinical and quality assessment reports, including assessment on the question and answer documents between the sponsor and agency and all annexes.
  • Assessment, reports and documents pertaining to post-approval variations, if applicable.
TGA
  • Complete clinical assessment reports, including assessment on the question and answer documents between the sponsor and agency and all annexes.
  • Complete chemistry and quality control assessment report, including assessment on the question and answer documents between the sponsor and agency and all annexes.
  • Assessment, reports and documents pertaining to post-approval variations, if applicable.
  • Delegate’s overview.
  • Pre-ACPM response.
  • ACPM minutes.

Note:

  • If these documentary requirements for the verification route are not fulfilled, the application should be withdrawn. Any fees paid will not be refundable. A new application can then be submitted via the abridged route.
  • Consult us before submission if the therapeutic product has been:
    • Designated an Orphan Drug by at least one reference drug regulatory agency
    • Approved by at least one reference drug regulatory agency via an accelerated/fast-track approval or under exceptional circumstances.

CTD checklists

Each application must be accompanied by a checklist, completed by the applicant and attached in PRISM.

Use one of the following application checklists for your choice of CTD. Each checklist provides details on the specific documents that need to be submitted with your application. Submit the completed checklist together with your application dossier for application screening.

Note: Your choice of CTD submitted for NDA will determine the submission format for the rest of your product life cycle. This means that future applications for changes to your registered product (variation application) will have to be in the same CTD format chosen here.

Fees and turnaround time 

Refer to therapeutic product fees and turnaround time for more information. 

How to apply

Submit your application through PRISM. Ensure you have the following before you access the e-service:

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).

Refer to our Guideline on PRISM Submission2051 KB for more details on how to submit.

More details on submission requirements may be found in our Guidance on Therapeutic Products Registration

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