Product Summary File (PSF) Preparation & Submission



Contents of the vaccine PSF

The PSF provides information on the product composition, manufacturing procedure, testing, stability, labelling, clinical experience and available post-marketing safety information.That is, it consolidates and communicates information relating to the manufacturing company and to the product that is required for evaluation for prequalification.

The contents of the PSF must include:

  • Chapter 1: General information
  • Chapter 2: Personnel
  • Chapter 3: Premises and equipment
  • Chapter 4: Vaccine composition, presentations and schedules
  • Chapter 5: Production
  • Chapter 6: Quality control
  • Chapter 7: Stability
  • Chapter 8: Clinical experience
  • Chapter 9: Production and distribution data
  • Chapter 10: Update on regulatory actions.

See below for further information and guidance on the information to be provided.

The PSF must be written entirely in English and provided in either Microsoft Word or as a PDF.

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.

Submission

Deadlines for submission

WHO has established three deadlines per year for eCTD 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.

NEEDS INFORMATION ABOUT WHERE TO SEND AND TO WHOM

Transition to CTD format

As of 1 January 2021, the eCTD format will be a mandatory requirement and PSFs will no longer be accepted. WHO already accepts applications in the (electronic) common technical document (eCTD) format provided that:

  • it includes a detailed cross-referencing of contents
  • information required by WHO but not included in the CTD requirements are presented.

Where the PSF cross-references to the CTD format, the documentation can be submitted in electronic form only. Electronic documents should be in searchable text where possible.