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Full evaluation route MAV-1 application guide

Follow this guide for the documentary requirements, fees and turnaround time of the MAV-1 application via the full evaluation route for CTGTP.

Eligibility

You must submit a MAV-1 application via the full evaluation route if the variation has not been approved by any of our comparable overseas regulator at the time of your application.

Pre-submission notification

Notify us at least two months before you submit your full evaluation application via email to HSA_CTT_Enquiry@hsa.gov.sg with the following information:

  • Product name.
  • Active ingredients.
  • Summaries of quality, non-clinical and clinical data (e.g. Module 2.4 Non-clinical Overview, Module 2.5 Clinical Overview)
  • Planned submissions in other countries.
  • Planned date of submission to HSA.

Note: You may request for a pre-market consultation with us if it is necessary to discuss specific areas related to your application, including the need for an overseas Good Clinical Practice (GCP) inspection, where relevant. Your meeting request to us must be made at least four 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

You must submit the application dossier within 2 working days of the application and organise it in either an International Council for Harmonisation Common Technical Document (ICH CTD) or ASEAN CTD (ACTD) format. You need to submit all documents in English.

Your application dossier must be submitted to us in a CD/DVD labelled with the following information:

  • Product name.
  • Application type.
  • Contents of the CD/DVD (e.g. Module 1).

Documents Location in ICH CTD Location in ACTD Required for MAV-1 full evaluation route
Administrative documents and product information Module 1 Part I  Yes
Common technical document overview and summaries Module 2 Incorporated into Parts II, III and IV  Yes
Quality documents Module 3 Part II  No
Non-clinical documents Module 4 Part III  No, unless the variation is related to non-clinical data, then non-clinical summary and non-clinical overview as well as relevant study reports is required.
Clinical documents Module 5 Part IV  Yes

Application checklists

Each application must be accompanied by an application checklist, completed by the applicant and attached in the online application form.

Use one of the following application checklists for your CTD format. Each checklist provides details on the specific documents that need to be submitted with your application.

Fees and turn-around-time

Refer to CTGTP fees and turn-around-time for more information.

How to apply

Submit your application through the relevant application form. Ensure you have the following before submitting your application:

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