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UK Offers 14-Day Approvals For Lowest-Risk Phase III/IV Trials

 
• By Vibha Sharma

The Medicines and Healthcare products Regulatory Agency says it is in “everyone’s best interest” if clinical trial sponsors seeking UK approval for low-risk Phase III and IV studies make use of its new notification scheme that will cut the 30-day statutory evaluation timeline by more than half.

Close-up at medium level of Risk assessment matrix table paper document. Industrial and business planning object. Selective focus at the medium text.
UK Is Taking A Risk-Proportionate Approach To Processing Initial Clinical Trial Applications • Source: Shutterstock

The UK has formally kick-started the overhaul of its clinical trials framework with the launch of a new notification scheme under which the regulatory evaluation timelines of the lowest-risk studies, for example some Phase III trials already authorized in the US or the EU, will be reduced by more than 50%.

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More from United Kingdom

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

Major Analysis To Help MHRA Fill Gaps In UK Clinical Trials Landscape

 
• By Vibha Sharma

A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.

UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 
• By Andrew McConaghie

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.

Trump’s Tariffs Will Lead To ‘Instability’ And ‘Less Investment’ In UK

 
• By Eliza Slawther

While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.

More from Europe

Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform

 
• By Eliza Slawther

Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

EMA Initiative To Address Information Overload In CTIS Training Materials

 
• By Vibha Sharma

The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.