The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 18 August 2026,
published a position paper clarifying
how microbiome-based medicines can be made
available for patients in the UK, encouraging
developers to pursue UK licencing pathways for this emerging
class of therapies.
Microbiome-based medicinal
products are medicines that work through
modulating, restoring or replacing the human microbiome.
They represent a promising new category of therapies
with the potential to address areas of significant unmet clinical
need such as antimicrobial resistance (AMR).
The MHRA's position is that MBMPs fall within the scope of the
existing UK medicines regulatory framework, set out in the Human
Medicines Regulations 2012. This provides developers with a clear
route to licencing, while maintaining the same robust
standards of quality, safety and efficacy that apply to all
medicines in the UK. Depending on their characteristics, MBMPs
may be regulated as biological medicinal
products, or in some cases may meet the criteria for
advanced therapy medicinal products (ATMPs).
No MBMP currently holds a UK marketing authorisation. Some
countries have authorised a small number of donor-derived
microbiota products for Clostridioides difficile (C.
difficile) infection.
The MHRA's position paper sets out some of the
key scientific and regulatory steps developers should
consider, including product characterisation, manufacturing
consistency, control of batch-to-batch variability, safety
assessment (including antimicrobial resistance risk), and
generation of robust clinical evidence.
Beach, Executive Director
of Healthcare Quality and Access at the MHRA,
said:
Microbiome-based medicinal products represent one of the most
interesting and fast-moving areas in medicine today.
Our position paper gives developers the clarity
they need to bring these innovations forward with confidence,
while ensuring patients continue to be protected by the same
rigorous standards that underpin all licensed medicines in the
UK.
The UK's existing, proportionate and evidence-based
licensing frameworks are ready to support this field. Early
engagement with us is the best way for developers to navigate it
successfully.
The MHRA is encouraging developers to make use of its Innovation
Office and Scientific Advice services at an early stage, to
clarify the applicable regulatory framework, agree proportionate
development strategies and de-risk investment decisions ahead of
pivotal trials.
The position paper also clarifies existing
arrangements for faecal microbiota transplantation (FMT) in the
UK. FMT is currently used for specific indications, most notably
recurrent Clostridioides difficile infection, and is supplied
either through clinical trials or as an unlicensed medicine under
MHRA specials manufacturing arrangements or extemporaneous
preparation. These routes remain under the direct
responsibility of the prescribing clinician and are unaffected by
today's publication.
The MHRA also notes ongoing developments internationally,
including the EU's Substances of Human Origin (SoHO) Regulation,
which will introduce a distinct framework for intestinal
microbiota interventions in the EU.
Notes to Editors
