United Kingdom
The MHRA’s new scientific dialog program will offer drug developers “closed-door meetings” that will offer “confidential, commercially sensitive discussion” with its staff to help them “refine” their real-world evidence generation strategies.
The UK’s “world-first” tailored regulatory framework for point of care manufacturing is set to enter into force this summer.
“Significant progress” has been made in setting up the UK’s Rare Therapies Launch Pad pilot scheme, which will construct a “new regulatory pathway tailored specifically for ultra-rare diseases,” a senior scientist involved in the project says.
New regulations on clinical trials should help the UK remain a popular destination for multinational trials, according to the MHRA, the country’s medicines regulator.
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.
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.
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.
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.
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.
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.
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.
The MHRA is taking steps to embed “meaningful and impactful” patient involvement across its regulatory pathways.
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.
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.
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.
Some stakeholders say that the entry criteria for the licensing and access pathway have been too broad, leading to an overburdening of the scheme.
The deadline for comments is nearing for a draft UK guidance that seeks to increase inclusivity and diversity across clinical trials and investigations.
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.
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.”
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.