The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
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MHRA Safety Roundup: September 2025
Summary of the latest safety advice for medicines and medical device users
Form: Decentralised Manufacture: The designation step application form
Application Form to be completed by an Applicant and sent to the MHRA requesting consideration of an award of a Decentralised Manufacture (DM) Designation.
Guidance: AI Airlock Background
Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.
Paracetamol and pregnancy – reminder that taking paracetamol during pregnancy remains safe
Patients should be reminded and reassured that there is no evidence that taking paracetamol during pregnancy causes autism in children. Paracetamol is recommended as the first-choice pain reliever for pregnant women, used at the lowest dose and for the shortest duration. It also acts as an antipyretic and is therefore used to treat fever.
Field Safety Notices: 02-06 February 2026
List of Field Safety Notices: 02-06 February 2026
MHRA approves inavolisib for the treatment of breast cancer
The MHRA has today, 26 November 2025, approved inavolisib (Itovebi) for the treatment of adults with a type of breast cancer called HR-positive
