We welcome the willingness of the MHRA to adopt a flexible approach to accelerating the authorisation of the use of phage therapies and its offer to work with phage innovators to support their development. However, the MHRA should provide clarity on how different pathways for developing phages, such as the Innovative Licensing and Access Pathway, and other flexible regulatory approaches will work in practice and how they will align with GMP and non-GMP phage for compassionate use in last resort cases. We recommend that the MHRA publishes guidance on how it intends to regulate phages if they are not produced using a GMP approach. This should include guidance on what developmental pathways are available to phage innovators. (Paragraph 94) Phage clinical trials