The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will consider fast-tracking approval applications for medicines when there are “compelling reasons for believing that the product would provide a major breakthrough in the treatment of patients for certain conditions”, the agency says.
The MHRA has an established procedure that allows marketing authorisation applications to be dealt with more quickly under special circumstances. The agency has now issued guidance on its website explaining when and how these conditions apply.
There are two basic criteria for fast-tracking: major therapeutic breakthroughs and supply shortages. In the first case, the categories that may be eligible for accelerated approval are:
- chronic, debilitating diseases for which available treatments are ineffective or otherwise inadequate;
- severe or life-threatening diseases for which available treatments are ineffective or otherwise inadequate;
- the emergence of a disease with widespread resistance to treatment with currently available therapeutic agents;
- the emergence of a new disease entity with severe or life-threatening effects and for which currently available treatments are ineffective or otherwise inadequate.
Approval applications and imports of unlicensed products may also be fast-tracked where essential medicines are in short supply, the guidance notes.
This policy would be considered “where there was a scarcity (actual or high probability) of essential medicines, where there was a lack of suitable alternative suppliers or alternative treatments, and in circumstances that had the potential to impact adversely on public health”, the MHRA states. Moreover, implementing these procedures “would be expected to minimise any negative impact on public health due to shortage”.
In both of the situations outlined above, fast-tracking means the MHRA would start assessing the application “out of turn, ahead of its order in the sequence of submitted applications”. A decision either to agree or refuse a request for fast-tracking would have no implication for the determination of the application in any respect other than the date of the commencement of its assessment”, the guidance stresses.