UK Plan to Fast-track Drugs Approved by ‘Trusted’ Regulators in Other Countries — One Step Closer to a ‘One Health’ World?

 The U.K.’s drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), is weighing a plan that would result in what The BMJ has described as “near automatic sign off” for medicines “already approved by ‘trusted’ regulators in other parts of the world.”

The proposal is raising concerns among some medical experts.

According to a JD Supra article, these “new international recognitions routes” announced by the MHRA are intended for the quick “approval of medicines that are already authorised in Australia, Canada, the European Union (EU), Japan, Singapore, Switzerland or the United States.” The new “routes” are expected to begin by Jan. 1, 2024.

Medications already licensed in any of these “trusted partner” countries would receive “a fast-track U.K. application process.”

The plan builds on the MHRA’s existing European Commission (EC) Decision Reliance Procedureand also “complements the U.K. national authorisation process and accelerated access route, the Innovative Licensing and Access Pathway (ILAP).”

This procedure was introduced following Brexit to allow the MHRA to “rely” on drug approvals from the European Medicines Agency (EMA). If a drug has received EMA approval or a “positive recommendation,” the MHRA can then proceed with a “lighter touch” assessment and “accelerated decision from the MHRA within 67 days or less.”

In March, the U.K. government awarded the MHRA £10 million ($12 million) in funding “to help bring innovative new medicines and medical technologies to U.K. patients more quickly.”

Describing this new process as a “milestone,” JD Supra claimed it “is intended to result in faster access for U.K. patients to new innovative medicines.”

The Association of the British Pharmaceutical Industry said the process will reduce “the time delay for regulatory approval.”...<<<Read More>>>....