The U.K. Medicines and Healthcare Products Regulatory Agency is reminding industry that several new regulatory requirements are in effect as of June 16, 2025, such as a postmarket surveillance rule that says manufacturers have only 15 days to report serious incidents to the agency.
The U.K. government has announced the latest measures to speed up and expand clinical trials, launching Be Part of Research, a central national register where people can search and sign up to take part in studies.
The U.K.’s National Health Service reported June 10 that patients in the U.K. will be the first in Europe to enjoy the benefits of the Edison ultrasound histotripsy for ablation of liver cancer tumors as part of an effort to bring products to market more quickly to deal with unmet needs.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued its first official guidance on how to develop bacteriophages as licensed medicinal products. This covers personalized phage therapies designed for specific patients – at present the only form in which they are available – but also is relevant to the development of off-the-shelf products for treating common infections.
The EMA has issued a new guideline on how to include and/or retain pregnant and breastfeeding women in clinical trials, in a move that it says “marks a change in the paradigm.” The aim is to ensure that trial sponsors generate robust clinical data in these populations.
The U.K. Medicines and Health Care Products Regulatory Agency posted a draft guidance on the use of real-world evidence to serve as a control arm for clinical trials.
As new clinical trials regulations were signed into law in the U.K., an analysis of 4,616 submissions to conduct studies has highlighted what is required for the updated law to translate into a more efficient, streamlined and adaptable regulatory framework.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) unveiled the pilot version of its AI Airlock in 2024, and the agency posted a list of the products that are taking part in this version of a regulatory sandbox.
Entrada Therapeutics Inc. has received authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and research ethics committee to initiate a phase I/II study of ENTR-601-45 for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation in the DMD gene amenable to exon 45 skipping.
The U.K. Medicines and Health Care Products Regulatory Agency reported a pilot program for the use of RWE in regulatory decision making, which is largely directed toward drug products.
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