United Kingdom

UK Proposes Simplified Consent Method For Low-Risk Trials

 
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The UK’s proposed approach to recording informed consent for lower-risk trials is designed to ensure that patients still receive the critical information they need to consider participation, but are supported to give their consent in an easier way.

UK MHRA Reminds Industry Of Looming Deadline For New Packaging Requirements

 

More than 90% of companies have submitted new medicines packaging artwork to the UK’s drug regulator, the MHRA. The agency urges the remaining marketing authorization holders of its 31 December deadline to comply with the new Windsor Framework arrangements.

UK's Clinical Trials Diversity Draft Gets Over 200 Stakeholder Responses

 
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As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.

UK MHRA Calls On Pharma To Embrace RWD Early

 

The UK’s MHRA is urging drug companies to engage in discussions on their strategies relating to using real-world data earlier in their development cycle.


England’s Funding Rejection For Enhertu At Odds With 19 European Countries

 

NICE, England’s health technology assessment institute, says it was unable to reach a price agreement for AstraZeneca/Daiichi Sankyo’s HER2-low breast cancer drug Enhertu, breaking a line of 21 positive recommendations for breast cancer therapies.

AstraZeneca: AI Regulations ‘Tricky’ To Interpret & Navigate

 

The pharma industry wants regulators around the world to engage with companies and “articulate the value added” when introducing new regulations and guidance around the use of AI in drug development, AstraZeneca’s director for data and AI policy says.

UK MHRA’s ILAP: High Interest But Low Uptake Of Benefits

 

While many companies demonstrated an interest in the UK’s licensing and access pathway for innovative medicines, few made use of the various benefits the scheme had to offer, the MHRA said.

UK Regulator Wants More Patient Input At Pre-Authorization Stage

 
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The MHRA is taking steps to embed “meaningful and impactful” patient involvement across its regulatory pathways.


New UK Rules On Supplementary Protection Certificates – Will You Be Affected?

 
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Companies are being encouraged to look at whether they will be impacted by new UK rules on supplementary protection certificates that come into effect from the beginning of next year.

UK MHRA: ‘At Least Half’ Of Novel Drug Filings To Take National Assessment Route

 
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With approval applications for new active substances expected to rise by 25% by 2026, the UK regulator says it wants to focus its national assessment procedure on new innovative therapies. It will also review progress with the new International Recognition Procedure.

ACCESS Consortium Exploring Clinical Trials Collaboration & Reliance, Says UK MHRA

 

The UK’s drug regulator, the MHRA, is exploring new opportunities to work closer with its counterparts from Australia, Canada, Singapore and Switzerland under the ACCESS Consortium group, with a focus on pre-submission scientific advice.

‘New Era’ To Begin For UK’s ILAP In 2025, With Focus On ‘Transformative’ Drugs

 
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Some stakeholders say that the entry criteria for the licensing and access pathway have been too broad, leading to an overburdening of the scheme.


Industry Wants UK Clinical Trial Diversity Plans To ‘Work Alongside’ Global Regulations

 

The deadline for comments is nearing for a draft UK guidance that seeks to increase inclusivity and diversity across clinical trials and investigations.

Generics Industry Sounds Alarm Over Northern Ireland Requirements As Deadline Looms

 
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With a looming deadline of 1 January 2025 for firms supplying Northern Ireland to comply with the Windsor Framework, UK generics and biosimilars association the BGMA has warned of potential supply interruptions due to requirements that include a “UK only” label for all packs as well as UK-based batch testing for biologicals.

UK’s ‘World First’ Point Of Care Manufacturing Rules Enter Parliament

 

The UK government has introduced draft legislation that will regulate the manufacturing of innovative medicines such as cell and gene therapies at the point of care. The country’s medicines regulator, the MHRA, says the framework is the “first of its kind in the world.”

Déjà Vu In England: Lilly’s Alzheimer’s Drug Kisunla Gets MHRA Yes, But NICE Says No

 

The UK’s drug regulator has approved Eli Lilly’s early Alzheimer’s drug Kisunla, but England’s health technology assessment agency NICE said that the product “does not currently demonstrate value” for the National Health Service.


New UK Clinical Trials Regulation Expected To Apply From January 2026

 

Sponsors can expect to see a copy of final guidance on how to comply with the UK’s new clinical trials regulation in August 2025, while the new framework is set to apply from January 2026.

ATMPs: Practical Hurdles Hamper International Regulatory Collaboration

 

Regulators from the US, EU, Japan and UK discuss the merits of regulatory convergence for cell and gene therapies, but say that practical challenges often limit their ability to align on pharmaceutical regulatory processes.

Has Competition Reassurance Helped Counter Combination Woes In The UK?

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

The ‘Unintended Consequences’ Of UK's New Pricing Scheme

 
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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.