CTD Preparation & Submission
Contents of the vaccine CTD
Module 1 contains information not included in Modules 2, 3, 4 or 5 but that is required to assess the product for prequalification purposes. See below for further information and guidance.
Modules 2,3,4 and 5 share the common format and content of dossiers submitted to other authorities, according to the following major headings:
- Module 2: Common Technical Document Summaries (As per ICH guidelines M4Q, M4S, M4E)
- Module 3: Quality (as per ICH M4Q)
- Module 4: Nonclinical Study Reports (as per ICH M4S)
- Module 5: Clinical Study Reports (as per ICH M4E)
See below for further information and guidance. For a full description see the International Council for Harmonisation (ICH) guidance.
The CTD must be written entirely in English and provided in either Microsoft Word or PDF electronic, searchable versions.
Liaising with the national regulatory authority
Since reliance on effective regulatory oversight by the national regulatory authority (NRA) of the country of manufacture plays a critical role in the system, manufacturers are required to engage with NRAs from the beginning of the prequalification application process and to complete the following steps:
- inform the NRA of their application to WHO for the vaccine prequalification by sending to the NRA a copy of the application letter sent to WHO
- request the NRA to participate/collaborate in the process
- provide the NRA with the necessary authorization to discuss the relevant files with WHO representatives.
Before submitting a product summary file (or common technical document) in application for WHO prequalification, manufacturers must also obtain a marketing authorization from the responsible NRA. The marketing authorization demonstrates that the NRA has conducted the required regulatory oversight – review and assessment – of the product and grants it a licence to be marketed.
Deadlines for submission
WHO has established three deadlines per year for CTD submission:
- 31 January
- 31 May and
- 30 September
Any application must arrive at WHO no later than the submission date if it is to beconsidered for the subsequent round of review. Applications received after the submission deadline will not be considered for evaluation until the following review round.