The UK might reciprocate American FDA drug approval

The UK might reciprocate American FDA drug approval to accelerate the British drug approval process.

The Food and Drug Administration (FDA) is responsible for approving drugs for disease treatment in America. Typically, before a new cancer drug is approved for usage in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), which has a separate approval process, the drug will initially get approved for usage in America by the FDA first. The FDA review process of a new drug application, that contains all of the important study results from pre-clinical to phase III clinical trials, takes between 6-10 months. It can take 10-15 years to generate the study results that are required to make an FDA drug application and a recent study has estimated this costs an average of $1.3 billion. 

The MHRA are currently developing a new international framework and although details are scarce, analysts are optimistic that if a drug is initially approved by the FDA, subsequent MHRA approval may be reciprocated in a swift manner, accelerating the overall time taken for the drug approval process in Britain. Reciprocal FDA approval might happen as quickly as early 2024, although many key details are yet to be announced by the MHRA. 

Currently, the MHRA have a procedure in place called The European Commission Decision Reliance Procedure.This procedure was introduced after Brexit as a way of ensuring British patients were not denied access to new medicines as a result of the the new requirement that they need to be separately authorised by the MHRA, as European Commision approval alone would no longer be sufficient. This procedure has just been extended by one year and expires in December 2023. Currently, if the European Commission provides a positive decision for a drug, the MHRA will aim to reciprocate this decision by 67 days because of this procedure. Currently, outside of this reciprocal procedure, high quality applications for medicine approval by the MHRA take place over two phases, with a 150-day timeline, although an additional 60 days can be added on, if required. 

In January 2023 the MHRA announced the new international recognition framework will be implemented from 1st January 2024. They state “Our aim is to extend the countries whose assessments we will take account of, increasing routes to market in the UK. We will communicate who these additional regulators are and publish detailed guidance about this new framework in due course, including any transition arrangements for applications received under existing frameworks.” 

If countries, such as America, are added to this scheme, the drug approval process will be greatly accelerated for British medicines. This will mean a much quicker turnaround time for new drugs showing positive results in clinical trials getting to British patients.