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The Medicines and Healthcare products Regulatory Agency (MHRA) is working to make it easier for medicines with UK approval to also be approved in India and the United States, and vice versa, its chief executive has said.
Speaking to attendees at the Medicines UK conference, held on 14 July 2026 in London, Lawrence Tallon noted that the UK was a relatively small market for medicines supply since leaving the EU, and therefore potentially less attractive to pharmaceutical investment.
“However, if they realise that accessing the UK market, getting the MHRA seal of approval will open up multiple other jurisdictions, then it becomes a much more attractive prospect to design, to build and design in the UK and go into market in lots of other jurisdictions,” he added.
In particular, Tallon said that India was a “crucial” jurisdiction to partner with but would need support to build trust in its regulatory processes, including through inspections of manufacturing sites and product recalls, where necessary.
“If we look at where the volume is, where the growth is going to be in the decades ahead and we look at commonalities of things like language and legal frameworks, we really want to have that same situation with India, whereby we can say that there is regulatory recognition and reciprocity between our countries,” he said.
Tallon also noted that to “get to the stage where [the Indian regulator] CDSCO [Central Drugs Standard Control Organization] is recognised as one of the global standard centres”, the MHRA could help with capability building and quality improvement within CDSCO.
“We want the whole global community to look at manufacturing in the pharmaceutical industry [in India] and have very high levels of trust in that sector, and there is some work to do because at the moment those trust levels are not there ubiquitously across the board,” he continued.
“So if that means that we have to do some inspections that land some tough messages, and if we have to recall some products, ultimately that’s about moving the quality bar up. So it’s difficult, it’s tricky, but if we don’t do it, we won’t build trust.”
Tallon also highlighted that the MHRA was also prioritising relationships with the United States and the Access Consortium, which brings together regulators from the UK, Australia, Canada, Singapore and Switzerland.
“America is very, very important to us because [it is] 40% of the global market, people will always design for the United States. We need to make sure that it’s an easy transatlantic bridge, which is why a couple of weeks ago we announced a new status between ourselves and the FDA [US Food and Drug Administration], where we will have a liaison office in the FDA in Washington, and they will have a liaison office with us in London.
“This puts us in a different position in terms of that transatlantic group. So, design [and] approve a new [ product in the] UK, go to market in the United States,” he said.
“Of course, Europe remains important, and we do not want regulatory friction with Europe wherever that’s possible, [but] there will be some areas where we will reserve the right to go our own way, particularly around novel products and innovation.”
“In areas like cell and gene therapies, in AI, and some of the other innovative things we do, I do think we will see some divergence”, Tallon suggested, adding that the MHRA may be able to “move faster” than its EU counterpart, the European Medicines Agency.
