Full evaluation route for MAV-1 application

Follow this guide for the documentary requirements, fees and turn-around-time of the MAV-1 application of a therapeutic product via the full evaluation route.

Eligibility

You must submit a MAV-1 application via the full evaluation route if the major variation has not been approved by any drug regulatory agency at the time of your application.

Pre-submission notification

Notify us at least two months before your intended submission date 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. 

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
Administrative documents and product information Module 1 Part I
Common technical document overview and summaries Module 2 Incorporated into Parts II, III and IV
Quality documents Module 3 Part II
Non-clinical documents Module 4 Part III
Clinical documents Module 5 Part IV

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 your original NDA will determine the submission format for the rest of your product's post-approval applications.

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