MHRA backs microbiome-based medicines and pilots cut to clinical trial approvals

Microbiome-based medicines are an emerging class of potentially highly innovative and personalised treatments. They are products that can alter, replace or restore the collection of microorganisms that live in and on the human body, together with their genetic material. Currently, no MBMP has been approved for sale in the UK, though some products have been used in clinical trials and been supplied under special unlicensed manufacturing arrangements.

In a new position paper, the Medicines and Healthcare products Regulatory Agency (MHRA) said it “considers MBMPs acceptable in principle and capable of meeting UK regulatory standards for marketing authorisation”. It said that, depending on their characteristics, they could be regulated as biologics or advanced therapy medicinal products (ATMPs) – a category of products that covers things like cell and gene therapies.

“The UK takes a science-led, enabling approach to MBMPs,” the regulator said. “The MHRA wishes to encourage the development and use of products which have been licensed with appropriate evidence.  The supply of unlicensed products in the UK remains important for patient treatment until we have licensed treatments available.”

Separately, the MHRA has announced a new pilot programme designed to speed up the approval of certain “low-risk” ‘phase one’ clinical trials. Under the pilot, the proposed clinical trials will be assessed over a period of just two weeks before a decision on whether to approve them will be made.

The MHRA said only phase one trials involving healthy adult volunteers in the UK will be eligible for the fast-track approval process during the pilot. The MHRA has set out a range of further “inclusion” criteria that researchers will have to satisfy, as well as “exclusion” factors that they need to avoid. It said no exceptions will be made for projects that do not satisfy the eligibility requirements.

“Our goal is to provide the initial regulatory decision (first review outcome) in 14 days by 28 December 2026,” the MHRA said. “Even during the early pilot stages, the first-round review will be significantly quicker than the standard 30 days.”

Catherine Drew of Pinsent Masons, who specialises in medicines regulation, said: “Both of these developments demonstrate the desire of the MHRA to be seen at the forefront of innovation as a regulator and enabling accelerated access to patients in the UK for innovative therapies. There is already evidence for this in the MHRA-NICE aligned pathway, enabling publication of decisions on licensing and value in parallel and earlier NHS access, as well as in the adaptable licensing regime the MHRA has proposed for orphan medicines.”

“The MBMP position paper and announcement of a 14-day approvals pilot programme for certain phase one clinical trials are therefore the latest tools in the MHRA toolbox to accelerate approval of innovative medicinal products in the UK. They should enhance the reputation the UK has among the global pharma community as an important location for bringing products to market, to the benefit of UK patients,” she said.