Regulatory issues for phage‐based clinical products

Phage‐based therapeutic products are members of a growing and diverse group of products categorised as ‘biologics’, ‘biologicals’ or ‘biotechnological products’. They are regulated in much the same way as conventional drugs although in America they have their own division at FDA, the Centre for Biologics Evaluation and Research, ‘CBER’ (as opposed to ‘CDER’, the corresponding drugs division). The distinction is important because there are significant differences between the two divisions in the amount of toxicological characterisation, clinical testing and manufacturing data that must be submitted for approval. Also, there are important differences in the extent to which multiparty manufacturing arrangements are permitted. There are a number of regulatory issues surrounding phage‐based clinical products that, if addressed early during product development, will not become blocks to progress later on. The regulatory issues arise in part because of the unique nature of phage‐based clinical products and in part because of their intended clinical use.