mhra
Medicines for Human Use (Clinical Trials Amendment) Regulations 2025 coming into full effect on 28 April 2026
The UK’s clinical trials framework is set for a major update with the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 coming into full effect on 28 April 2026. This represents the most significant…
The MHRA-NICE Accelerated Aligned Pathway Pilot.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have launched the Accelerated Aligned Pathway pilot, a groundbreaking initiative designed to streamline the regulatory and health…
Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, so stop calling them so.
Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, therefore the very sexy terminology of ‘cancer vaccines’ is inappropriate. MHRA’s clarifies own definitions (https://assets.publishing.service.gov.uk/media/6799ef4d9a6dc0352ab34225/Individualised_mRNA_cancer_immunotherapies_0.6.5.pdf). More appropriately, MHRA states that such products are individualised…