Between 6 February 2025 and 28 February 2025, the following guidances issued by the MHRA were updated:
Guidance updated – Format and content of applications for agreement or modification of a Paediatric Investigation Plan
This guidance provides detailed information on:
- the required format and content of applications for agreement on or modification of a paediatric investigation plan (PIP)
- requests for waiver and deferrals
- the operation of the compliance check in accordance with the Human Medicines Regulations 2012 (HMRs).
It has been updated with respect to the Windsor Framework and clarity of instructions.
Source: MHRA
Guidance updated- Exceptions and modifications to the EU guidance on good pharmacovigilance practices (GVPs) that apply to UK MAHs and the MHRA
GVP are a set of measures drawn up to facilitate the performance of pharmacovigilance in the EU.
This guidance describes the aspects of the EU guidance on GVP that no longer apply to the MHRA and UK MAHs, or are to be read subject to modification.
Significant changes have been made to the guidance. They can be viewed clicking the link ‘See all updates’ on this page.
Source: MHRA
Guidance updated- Importing investigational medicinal products into Great Britain from approved countries
This guidance has been updated to to take account of the EU implementation of the Clinical Trials Regulation No 536/2014 related to EU QP certification.
Source: MHRA
Guidance updated – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
It has been updated to add latest version of Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority.
Source: MHRA
Guidance updated – Clinical trials for medicines: manage your authorisation, report safety issues
Updates have been made to to the section on development safety update reports(DSURs) including a new user reference guide. No further specifics have been provided.
Source: MHRA