Completed paediatric studies: submission, processing and assessment (DOCX)

Document information

ByMedicines and Healthcare products Regulatory Agencyslate_wren_e8a3fb

Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).

Adapted edition

Clinical trial compliance

Document type: Reference Guide
Format: DOCX
Pages: 5
Language: English
Version: 1.0
Updated: 2026-09-17
Category: Safety & operations
Licence: Open Government Licence v3.0

Description

Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs). Consult the original guidance for current legal and operational details.

Contents

1. Overview
2. Legal background and scope
3. Submitting information
4.Initial appraisal
4.1 Assessment of study data is not required
4.2 Assessment of study data is required
4.2.1 Limited evaluation
4.2.2 Full assessment
5. Studies remaining within EU framework
6.Contact

Source and licence

Completed paediatric studies: submission, processing and assessment

Medicines and Healthcare products Regulatory Agency

Original source OGL-UK-3.0

AttributionMedicines and Healthcare products Regulatory Agency, ‘Completed paediatric studies: submission, processing and assessment’ (updated 13 February 2025), reused under the Open Government Licence v3.0.

ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.

Version history