Abridged evaluation route for new drug application

Follow this guide on the NDA documentary requirements, fees and turn-around-time when registering your therapeutic product via the abridged evaluation route.

Eligibility

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

Priority review

You can request for a priority review for a life-saving drug if the drug is intended for treating:

  • A serious life-threatening condition and can address local unmet medical needs such as:
    • The absence of a treatment option.
    • Lack of safe and effective treatments, such that the drug would be a significant improvement compared to available marketed products, as demonstrated by:
      • Evidence of increased effectiveness in treatment, prevention, or diagnosis of a disease.
      • Elimination or a substantial reduction of a treatment-limiting adverse reaction.
  • Disease conditions of local public health concern, such as cancer and infectious diseases like dengue, tuberculosis, hepatitis and malaria.

To request for a priority review, state the request in the Introduction document of the application dossier and attach the relevant justifications and evidence such as:

  • The seriousness of the disease condition, local and worldwide mortality rates, anticipated morbidity and debilitation as a consequence of the disease.
  • Local epidemiology data and volume of requests through the exemption route on a named-patient basis.
  • The unmet needs, current available treatment options and standard therapies, and the inadequacy of current therapies.
  • The extent to which the product is expected to have a major impact on medical practice, its major benefit, and how it addresses the unmet needs.
  • Clinical evidence supporting the claims of significant improvement compared to available treatments.

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, CD/DVD or cloud-based file exchange software  (EasiShare). To request for access to EasiShare for dossier submissions, please click here.

CD/DVD submissions should be 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 abridged 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

If the NDA is for a non-prescription medicine, you may submit a written request for a waiver of clinical data submission. Eligibility for a waiver is subject to the criteria defined in Guideline on Submission for Non-Prescription Therapeutic Products165 KB.

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 turn-around-time

Refer to therapeutic product fees and turn-around-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