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.
You must submit a MAV-1 application via the full evaluation route if the major variation that has not been approved by any drug regulatory agency at the time of your application.
Notify us at least two months before your intended submission date through our online feedback form 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.
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:
|| 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
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