The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration are forging a new regulatory collaboration, setting up a liaison program that aims to foster speedier teamwork between the two countries when thorny drug and technology questions arise.
The program will establish dedicated officer roles for each agency at the FDA and the MHRA and will put particular emphasis on innovative medicines, medical devices and emerging technologies like artificial intelligence, the U.K. government explained in a Monday release.
All told, the plan is expected to help both agencies respond more nimbly to scientific advances and better support the development of products for patients across the countries, according to the MHRA.
“By creating dedicated liaison roles, we are taking our collaboration to a new level, improving how we share expertise, align on regulatory science and technology, and respond to the pace of innovation,” MHRA chief executive Lawrence Tallon said in a Jun. 16 statement, noting that the initiative is poised to help drugmakers “cross the Atlantic, in both directions,” with more “closely aligned” regulatory decisions.
“It is a hugely exciting moment and a powerful signal of our shared ambition, to lead internationally, to innovate together, and to deliver for public health on a Transatlantic scale,” Tallon explained.
FDA deputy commissioner for policy, legislation and international affairs Grace Graham agreed, commenting in the MHRA announcement that “American patients and innovators benefit when regulators collaborate.”
Importantly, both agencies will still maintain full regulatory independence and make their own independent regulatory decisions, the MHRA emphasized in the release. The plan was announced by Tallon and Graham at the Drug Information Association global annual meeting in Philadelphia at the start of the week.
The U.S. and the U.K. first shook hands on a significant pharma arrangement earlier this year with a landmark U.S.-U.K. trade deal. Under the accord, penned in April, two nations came to an agreement that allows the U.K. to avoid tariffs on imported medicines to the U.S. in exchange for boosting the net price its National Health Service (NHS) pays for novel treatments by 25%.
That development came shortly after the U.K. life sciences sector had been threatened by major global pharmas pausing or pumping the brakes on planned investments in the country, all against the backdrop of President Donald Trump’s Most Favored Nation pricing policies, which have, in part, called on other countries to pay a higher share for innovative medicines.
The arrangement was said to protect “a U.K. pharmaceutical industry that “added £28.5 billion to the UK economy in 2025,” the U.K. government said at the time. Global pharma heavyweights responded to the deal with tempered enthusiasm, with AbbVie’s chief commercial officer Jeff Stewart, for one, calling the agreement a productive “first step.”
The FDA and the MHRA first tested the waters of deeper regulatory collaboration in April, committing to work together to provide swifter access to cutting-edge medical devices and other medtech innovations in both countries. At the time, the two agencies also pledged to seek opportunities for “closer alignment” and “explore where future mutual recognition mechanisms may be appropriate," beyond the initial scope of the initial medical technology team-up.
Meanwhile, over at the FDA, some stable assistances from overseas could prove important as recent leadership changes have added to months of turmoil at the U.S. agency.
Last month, former FDA commissioner Marty Makary, M.D., retired from his post, leaving food deputy commissioner Kyle Diamantas to lead the agency at large in an acting capacity as it searches for a permanent replacement.