Full 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 full evaluation route.

Eligibility

You must register your therapeutic product via the full evaluation route if it has not been approved by any drug regulatory agency at the time of submission.

Pre-submission notification

Notify us at least two months before your NDA full evaluation submission with the following information:

  • Product name.
  • Active ingredients.
  • Summaries of quality, non-clinical and clinical data.
  • Planned submissions in other countries.
  • Planned date of submission to HSA.

Note: You may request for a pre-submission consultation meeting with us only if it is necessary to discuss specific areas of concerns related to your application. Your meeting request to us must be made at least three weeks before the proposed meeting date, with the meeting agenda clearly stated. Relevant documents such as presentation slides and briefing documents should be provided at least one week before the meeting.

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 full 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 Yes
Clinical documents Module 5 Part IV Yes
 

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