United Kingdom

A new UK medtech survey sets out industry’s market access and regulatory concerns and makes clear where system users see the need for improvement. There are some grounds for optimism, but the MHRA’s planned rise in regulatory fees could undo some of the good work.

With the UK generics market facing a rising number of supply issues, local off-patent industry association the BGMA has put forward a raft of policy proposals that it said could provide solutions.

The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.

September saw the extreme price rises of the last few months subside in the UK, albeit still seeing a handful of treble-digit percentage average increases for products like telmisartan.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

UK pharma also reaches agreement in principle, subject to DoJ approval, to pay $70m to resolve a whistleblower complaint filed by Valisure, the testing lab which in 2019 raised concerns about a potential link between the use of drugs containing ranitidine, a histamine-2 blocker, and cancer.

Issues raised in the first six months of the new VPAG include potential adverse impacts on both older and newer innovative drugs, as well as uncertainties over the “exceptional circumstances” clause that allows requests for price increases or cuts in repayment rates.

UK consumer healthcare industry association PAGB is calling on the UK government to explore the Rx-to-OTC switch of at least 25 OTC products over five years, and work with the country's medicines agency to re-evaluate the restrictive criteria for reclassification. 

Artificial intelligence and digital in healthcare are among four key scientific development areas that will benefit from the support of the UK Regulatory Innovation Office, the launch of which was announced by the government on 8 October.

Aspire Pharma has bolstered its dermatology portfolio by striking a deal to acquire “all assets” of another UK-based player, Canute Pharma.