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Verification or verification-CECA evaluation route for generic drug application

Find the documents, fees and turnaround time needed to register your generic drug through the verification or verification-CECA evaluation route.

Eligibility for verification applications

You may register your generic drug via the verification evaluation route if it meets the following criteria:

  • Has been approved by at least one of our reference drug regulatory agencies at the time of submission.
  • Has been approved within two years by the chosen reference agency.
  • Has a declaration letter by the product owner or applicant stating that all aspects of the product’s quality are identical to that currently approved by the chosen reference agency. This includes the compulsory submission of the unredacted and unedited assessment reports and supporting documents from the chosen reference agency.
  • Has not been rejected, withdrawn or approved via appeal process or pending deferral by a drug regulatory agency for safety or efficacy reasons.
  • The approval from the chosen reference drug reference agency was not obtained via an accelerated/fast-track approval or approval under exceptional circumstances.

Note: If a drug master file (DMF) is submitted, you must submit the unredacted and unedited assessment reports for the DMF and provide a separate declaration stating that the DMF you submitted is identical to the one submitted to the chosen reference agency. Refer to the Submission of Drug Master File for more information.

Eligibility for verification-CECA applications

You may register your generic drug via the verification-CECA evaluation route if it meets the following criteria:

  • Same eligibility requirements as verification applications listed above.
  • Generic drug must be manufactured in India.

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 GDA verification and verification-CECA routes

Administrative documents and product information

Module 1

Part I

Yes

Common technical document overview and summaries

Module 2

Incorporated into Part II

QOS

Quality documents

Module 3

Part II

Yes

Non-clinical documents

Module 4

Part III

No

Clinical documents

Module 5

Part IV

Yes

Note:
BE studies or biowaiver justification may be inserted in this section. Applicants submitting a GDA can refer to Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications95 KB for further details on product interchangeability and biowaiver requests


 Documents from chosen reference agency

For an application submitted under this route, you need to declare one of the reference drug regulatory agencies as the chosen 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 reference agency.

In the event that the chosen reference drug regulatory agency does not bear the most stringent indications, dosing regimens, patient groups and/or directions of use, the clinical assessment report from the reference drug regulatory agency that does meet these requirements should be submitted.

Primary reference agency Documentary requirements
  • Health Canada
  • USFDA
  • UK MHRA
  • EMA
  • Complete clinical 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.

Note:

  • If the reports do not meet the criteria, the application will be withdrawn and can resubmitted via the abridged route.
  • For verification-CECA applications, a valid Good Manufacturing Practice (GMP) certificate and the latest GMP inspection report as issued by the chosen reference drug regulatory agency must be submitted.

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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