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New UK Drug Applications At ‘Sustained Levels’ Post-Brexit

MHRA Vaunts ‘Exciting’ New Operating Model

 
• By Ian Schofield

The MHRA’s chief executive explains to the Pink Sheet how the agency will ensure the UK remains an attractive place to seek approval of new innovative drugs and build on the regulatory flexibilities introduced during the COVID-19 pandemic.

Closeup of mobile phone screen with logo lettering of UK MHRA agency, serum vials and syringe background - Image ID: 2H94BWR
The UK MHRA is undergoing a period of change • Source: Alamy

The UK Medicines and Healthcare products Regulatory Agency has painted a positive picture of its post-Brexit performance, saying that new drug applications have remained at “sustained levels” since the UK left the EU, and that the number of clinical trials is “buoyant.”

The agency also has an “exciting new operating model” that includes a new Innovative Medicines team, while its new international collaborations, such as Project Orbis and the Access Consortium, will ensure the UK remains “an attractive place”

More from Europe

Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By Vibha Sharma

While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
• By Eliza Slawther

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

EU HTA Regulation: How Rare Disease Drug Makers Can Meet Worrisome JCAs Data Requirements

 
• By Francesca Bruce

In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

More from Geography

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.