MHRA Puts Microbiome Medicines Inside the Existing Framework While the EU Builds a Separate One
- The MHRA published a position paper on 18 August 2026 stating that microbiome-based medicinal products fall within the existing UK framework set out in the Human Medicines Regulations 2012. Depending on characteristics they may be regulated as biological medicinal products, or may meet the criteria for ATMPs.
- No microbiome-based medicinal product currently holds a UK marketing authorisation. The agency notes that some countries have authorised a small number of donor-derived microbiota products for Clostridioides difficile infection.
- The MHRA flags the EU’s Substances of Human Origin Regulation, which will introduce a distinct framework for intestinal microbiota interventions in the EU. Regulation (EU) 2024/1938 entered into force in August 2024 and applies from 7 August 2027.
- Faecal microbiota transplantation is unaffected. It continues through clinical trials or as an unlicensed medicine under MHRA specials manufacturing or extemporaneous preparation, remaining the direct responsibility of the prescribing clinician. Named development expectations include product characterisation, manufacturing consistency, batch-to-batch variability control and antimicrobial resistance risk assessment.
CI read
Clarity is being read as an opening. It is closer to a closing. The MHRA has ruled out a bespoke regime for this class, so a microbiome product meets the same quality, safety and efficacy bar as any other biological. That is the clarification.
- No new pathway was created, and that is the news. These products sit inside the Human Medicines Regulations 2012 as biologicals or as ATMPs. Anyone expecting a proportionate category calibrated to live microbial consortia gets the standard biological dossier instead. Budget characterisation and batch control on that basis.
- The UK and EU now characterise the same product differently. The MHRA places intestinal microbiota interventions inside the medicines framework while the EU’s SoHO Regulation, which applies from 7 August 2027, will give them a separate one. One donor-derived product, two regulatory identities. Split the UK and EU dossiers now.
- Zero UK authorisations, and the route that actually treats patients is untouched. FMT continues under specials and extemporaneous supply exactly as before. A paper published on 18 August has moved no product to market, so the signal to watch is the first Scientific Advice outcomes and Innovation Office engagements, not the paper.