United Kingdom
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.
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.
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.
The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.
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.
NHS England says it is proposing a “realistic but challenging uptake trajectory” that will make “this clinically and cost-effective drug” available to as many patients as possible without overwhelming health care providers.
Hemgenix has now secured reimbursement in several European markets, with more talks ongoing. While the path to reimbursement has not always been easy, innovative access deals have helped to smooth the way.
Companies dealing with commercial costings or contracts with the National Health Service for early phase clinical trials or trials of advanced therapy medicinal products should soon be able to conclude their negotiations more quickly.
The ISRCTN clinical trials registry has launched an improved dashboard to provide metrics that reveal how many studies are complying with key transparency requirements. Badges are in place for individual studies meeting the transparency criteria.
The UK government should remove a cost-neutrality restriction on England’s health technology assessment institute, NICE, that limits the value it places on medicines for severe conditions, says industry body the ABPI.
There are increased complexities associated with potential regulatory divergence between the UK and the EU when the Medicines and Healthcare products Regulatory Agency takes over responsibility for UK-wide new drug approvals from January 2025, writes the ABPI's Rick Greville.
The newly published revised code of practice from the UK drug industry association moves certain elements from “guidance” to “mandatory” status, includes an option for providing prescribing information via QR codes, and promises to resolve complaints faster.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Reliance procedures have been used for most recent new drug approvals, and will continue to be employed in future, although the national approval route will play a key role in promoting innovation and protecting public health, says the UK regulator.