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Abridged evaluation route for generic drug application

Follow this guide on the GDA documentary requirements, fees and turnaround time when registering your generic drug via the abridged evaluation route.

Eligibility

You can register your generic drug via the abridged evaluation route if it has been approved by at least one drug regulatory agency at the time of submission. 

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).

You need to submit the following technical documents:
  • Complete quality documents for both the drug substance and drug product.
  • Bioequivalence (BE) studies or justifications for applying a biowaiver (if applicable).

Documents

Location in ICH CTD

Location in ACTD

Required for GDA abridged route

Administrative documents and product information

Module 1

Part I

Yes

Common technical document overview and summaries

Module 2

Incorporated into Part II

Yes, QOS only

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


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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