CTD Preparation & Submission

Global use of the common technical document (CTD) format has increased significantly since the last revision of the vaccine prequalification procedure. Most manufacturers have prepared a dossier in CTD format that they have used to register the product in one or more countries, and many countries that import prequalified medicines require submission of a CTD format dossier for registration of their products. Therefore, as of 1 January 2021, the CTD format will be a mandatory requirement. 
Adoption of a CTD-based format for the vaccine prequalification dossier should reduce the regulatory burden on companies since they will not need to maintain dossiers in multiple formats.

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.