MHRA Fast-Track Review for Novel Cannabis Formulations

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the introduction of an Innovation Passport fast-track pathway specifically applicable to novel cannabis-based medicinal product (CBMP) formulations. The move is intended to accelerate the availability of clinically promising treatments while maintaining rigorous safety standards.

How the Pathway Works

Under the existing Innovation Passport scheme, manufacturers of qualifying products can access rolling scientific advice from MHRA reviewers throughout the development process. The agency has now confirmed that CBMPs targeting unmet clinical needs — particularly paediatric indications and rare neurological conditions — will be automatically eligible for consideration.

Eligibility Criteria

• The formulation must target a condition with limited existing treatment options
• Phase II clinical data from UK or internationally recognised trial sites must be available
• The manufacturer must have a UK-registered entity or named UK regulatory lead
• A pharmacovigilance plan compliant with Good Pharmacovigilance Practice must be submitted at application stage

Industry Response

Several UK-based cannabis medicine developers have welcomed the change. Companies working on sublingual formulations for childhood epilepsy and topical preparations for inflammatory skin conditions cited the announcement as a significant catalyst for UK R&D investment.

"The MHRA has demonstrated that it understands the urgency felt by patients awaiting these treatments. The rolling review model removes months of unnecessary delay."

The MHRA stressed that the fast-track status does not lower the evidence bar required for marketing authorisation. Full efficacy and safety data remain mandatory. However, the new process allows manufacturers to receive iterative feedback, reducing the likelihood of late-stage application failure due to procedural gaps.