In a regulatory round-up, the U.K. Medicines and Healthcare Products Regulatory Agency opened a survey regarding in-house device manufacturing, the EU Notified Bodies staffed up last year and the Singapore Health Sciences Authority and the Hong Kong Department of Health agreed to share information.

The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions.

The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions.

Purespring Therapeutics Ltd. has received the go-ahead for a phase I/II trial of its investigational gene therapy PS-002 from both the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and the National Health Service Health Research Authority and Research Ethics Committee.

The U.K. Medicines and Healthcare Products Regulatory Agency unveiled another round of measures designed to promote access to the latest medical technology, which includes a move to jettison domestic device markings in favor of unique device identifiers.

The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.

The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.

Representatives of patients’ groups, industry bodies and venture philanthropy funders are calling for a renewal of the U.K. Rare Diseases Framework, to put fresh momentum behind translational research and clinical trials, streamline regulatory oversight and improve access to therapies.

The U.K. Medicines and Healthcare Products Regulator Agency dropped a guidance for digital mental health technologies that clarifies several key points, such as when the DMHT qualifies as software as a medical device.

The U.K. Medicines and Healthcare Products Regulatory Agency reported June 24 it joined a global regulatory network for AI that is part of the Health AI regulatory initiative – a program that will invite another nine regulatory agencies to take part in the initiative in the months ahead.