MHRA: Clear Pathway for Microbiome-Based Medicinal Products Licensing in UK

• The MHRA has published a position paper outlining its regulatory framework for microbiome-based medicinal products (MBMPs).
• Developers can navigate the licencing process with confidence, as MBMPs fall within the existing UK medicines regulatory framework.
• The MHRA is encouraging developers to engage early with its Innovation Office and Scientific Advice services to clarify the applicable regulatory framework.

The MHRA has issued a position paper outlining its regulatory framework for microbiome-based medicinal products (MBMPs), providing developers with a clear route to licencing in the UK. This move is expected to encourage investment and development of these innovative therapies, which have shown promise in addressing unmet clinical needs such as antimicrobial resistance. The MHRA's position is that MBMPs fall within the existing UK medicines regulatory framework, set out in the Human Medicines Regulations 2012, ensuring that developers can navigate the licencing process with confidence.

The regulation of MBMPs in the UK is guided by the Human Medicines Regulations 2012. Depending on their characteristics, these products may be regulated as biological medicinal products or advanced therapy medicinal products (ATMPs). The MHRA's position paper highlights the importance of product characterisation, manufacturing consistency, and control of batch-to-batch variability in ensuring the quality and safety of MBMPs. Additionally, developers must generate robust clinical evidence to support their licencing applications.

The MHRA's position paper is seen as a positive development for developers of MBMPs, providing clarity on the regulatory framework and encouraging them to pursue UK licencing pathways. The agency is urging developers to engage early with its Innovation Office and Scientific Advice services to clarify the applicable regulatory framework and de-risk investment decisions ahead of pivotal trials. This guidance is expected to support the growth of this emerging field in the UK.

Lawyers advising clients in the development of microbiome-based medicinal products should note that the MHRA has clarified its regulatory framework for these products, providing a clear route to licencing and encouraging developers to pursue UK pathways. This may impact investment decisions and development strategies, and lawyers should advise their clients on how to navigate this new guidance.

Source: Original reporting via Medicines and Healthcare products Regulatory Agency