Executive Intelligence
Life Sciences Reports
Regulatory, funding, leadership, market and commercial updates selected for life-science executives.
Clinical trials for medicines: modifying a clinical trial approval
Guidance on the various types of modifications that can be made to a clinical trial approval.
Read full reportFDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices
The U.S. Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics
Read full reportMHRA advises against the use of rectal catheters in infants
MHRA advises parents and healthcare professionals against the use of rectal catheters (known as gas and colic relievers) in babies.
Read full reportAll rectal catheters (gas and colic relievers): Do not use in infants, including for the treatment of colic, gas-related discomfort or constipation (DSI/2026/008)
Do not use rectal catheters in infants, including for colic, gas-related discomfort or constipation. Stop using these products immediately and dispose of any unused devices.
Read full reportField Safety Notices: 10 to 14 August 2026
List of Field Safety Notices from 10 to 14 August 2026.
Read full reportMHRA sets out position on regulation of microbiome-based medicinal products
MHRA publishes position paper clarifying the UK licencing route for microbiome-based medicines, supporting developers to bring these innovative therapies to patients.
Read full reportPolicy paper: UK Position Paper on Microbiome-Based Medicinal Products (MBMPs)
MHRA position paper, to help encourage the development and licensing of Microbiome-Based Medicinal Products (MBMPs) products in the UK.
Read full reportCorporate report: MHRA-NICE Real-World Evidence Scientific Dialogue
A programme to help decision making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations.
Read full reportMHRA consultation on statutory fees (2026)
Proposals for ongoing cost-recovery and to fund higher value services.
Read full reportNational Patient Safety Alert: ResMed Astral 100 and 150 Ventilators: Potential for Patient Harm due to Unexpected Interruption of Ventilation Therapy (NatPSA/2026/004/MHRA)
ResMed has issued a Field Safety Notice regarding Astral 100 and 150 ventilators and associated Printed Circuit Board Assembly spare parts manufactured prior to October 2024. A fault in the device can cause unexpected interruption of ventilation therapy.
Read full reportGuidance: Clinical trials: Phase 1, 14-Day Pilot Programme
The pilot aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.
Read full reportVimseltinib (romvimza) approved for use in adults to treat tenosynovial giant cell tumours
As with any medicine, the MHRA will keep the safety and effectiveness of vimseltinib (romvizma) under close review.
Read full reportMedicines: get scientific advice from the MHRA
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Read full reportFDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies
The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Simparica TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs and puppies.
Read full reportCOVID-19 test approval: how to apply
How manufacturers or distributors of Coronavirus (COVID-19) test devices can apply for approval of their tests to be placed on the UK market.
Read full reportYou’ve got the grades, but don’t pass on your health
Medicines and medical devices regulator issues health advice for teens off to university.
Read full reportCorporate report: MHRA quarterly Results and Forecast: 2026 to 2027
Quarterly reports to provide performance information and projections across 2026/2027.
Read full reportMHRA reaffirms the safety of childhood vaccination
Vaccination is one of the most effective and safest ways to protect against many serious infectious diseases
Read full reportTransparency data: Medicines and Healthcare products Regulatory Agency spending over £25,000: 2026 to 2027
Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.
Read full reportTransparency data: Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2026-27
HRA transactions over £500 made using the government procurement card (GPC).
Read full reportTransparency data: Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2025-26
MHRA transactions over £500 made using the government procurement card (GPC).
Read full reportDecision: Human and veterinary medicines: register of licensed manufacturing sites
The MHRA register of licensed manufacturing sites: manufacturer specials - human (MS) and manufacturer specials authorisation - veterinary (MANSA) only.
Read full reportNotice: Register of brokers authorised to deal in human medicines
Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.
Read full reportDecision: Medicines: new manufacturing and wholesale dealer licences
List of sites granted a manufacturer or wholesale dealer licence.
Read full report