Joint Statement from the UK Space Agency, the Medicines and Healthcare products Regulatory Agency, the Regulatory Innovation Office and the Civil Aviation Authority

The Commission on Human Medicines (CHM) has temporarily restricted use of the IXCHIQ Chikungunya vaccine in people aged 65 years and over following very rare fatal reactions reported globally. This is a precautionary measure while the MHRA conducts a safety review. The IXCHIQ vaccine will be available on the UK market from 18 June 2025.

Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.

Summary of the latest safety advice for medicines and medical device users

Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect programme.

How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

Syri Limited, T/A SyriMed is recalling batches of product as a precautionary measure due to crystallisation observed over time in the oral solution.