Regulations

If you could ask the regulators one question, what would it be?

Microbiome Therapeutics Regulations

The regulatory landscape for microbiome therapeutics leaves much to the imagination. And, when it comes to developing these products, this lack of direction is adding limitations to the industry's true understanding of what it takes to achieve regulatory compliance, and how close they are to meeting the necessary standards.This was made clear when respondents were asked: 'If you could ask your regulatory authority one question anonymously, what would it be?' The sheer range of answers (on the following page) show a level of frustration at the current guidelines.

However, this uncertainty doesn't appear to have yet affected the industry too negatively. When asked about the impact regulatory agencies have had on their company's success in the field (where 1 = Major Negative and 5 = Major Positive), most respondents (53%) revealed they have had a neutral impact - neither positive nor negative.

Interestingly, despite the differences between European and US regulatory requirements, we saw a similar response from both regions - both averaging neutral to positive ratings out of five.

Microbiome Therapeutics Regulations

If you could ask your regulatory authority one question anonymously, what would it be?

When will we receive the regulation on probiotic products?
How do we avoid being seen as a combination product?
What is the most appropriate regulatory path for the approval of microbiome products?
What pre-clinical data is needed for live bio therapeutics to enter clinical trials?
What is safety data expected?
What are the standards for donor selection?
How could multi-organism combination products be treated as drugs and why do they have to follow the same regulations of drug development?

How will you manage the submission of a clinical trial for a consortium of bacteria?
How are you and will you be classifying FMT based products for licensure?
What evidence will be required for a microbiome therapeutic for regulatory approval?
How are you going to cope with GM microbes as therapeutic agents in the community setting?

*Excluding Not applicable (46)