Euro Roundup: UK aims to speed market access by 6 months by coordinating MHRA, NICE reviews

The UK has set out plans to get new medicines to patients three to six months sooner by coordinating regulatory and reimbursement processes.

Under the UK’s 10-year health plan, the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have until April 2026 to launch a joint process. The plan is to use information sharing and joint scientific advice to accelerate decisions and cut administrative burdens.

The government provided more information about the joint process this week. Pharma companies will be invited to register early with MHRA and NICE under a joint information sharing agreement to support parallel decision-making over licensing and value.

By running MHRA and NICE processes in parallel, the government is aiming to eliminate the lag between a drug winning approval and being paid for by the health service. Officials predict increasing the number of medicines that are approved and licensed for use at the same time will allow patients to receive some drugs three to six months earlier than under the current sequential decision model.

Companies that want to participate in the process should register their products on UK PharmaScan, the national horizon scanning database, at least three years before their expected marketing authorizations. Registered companies will unlock an integrated advice service and an aligned pathway that are designed to streamline regulatory and health technology assessment requirements.

The joint process builds on existing efforts to accelerate NICE reviews. Sam Roberts, chief executive of NICE, said the organization reduced the time between license and guidance by 26% in the year to March.

Press Release

MHRA shares vision for planned UK early access service for innovative medical devices

MHRA has outlined plans to establish an early access service to provide time-limited, conditional access to promising medical devices ahead of full regulatory approval.

The UK agency piloted an Unmet Clinical Need Authorisation tool as part of its work on the Innovative Devices Access Pathway. MHRA sees the early access service as a way to turn the tool into a permanent part of its offering. Informed by feedback on the pilot, officials plan to extend the use of the tool beyond innovative pathways.

MHRA said the service will offer conditional market access for innovative devices that address clearly defined unmet clinical needs or that have the potential to significantly improve patient outcomes. The service will offer a bridging scheme to maintain patient access to devices where the clinical investigation has ended and the manufacturer is still awaiting regulatory approval, MHRA said. The agency will expect companies that come to market via the conditional pathway to keep working toward full approval.

Initially, MHRA will focus the early access service on innovative diagnostic devices. MHRA is particularly interested in supporting diagnostics that address the most urgent needs and financial sustainability of the UK health service.

Through the early access program, MHRA will offer participants advice and guidance on whether their device qualifies for the service, for a set fee. The agency will give companies milestones, documentation expectations and benefit-risk criteria to inform planning and regulatory engagement for each product.

MHRA is now working to refine the service and establish internal capabilities to support early access.

MHRA Statement, Press Release

EMA finalizes opinion on modeling software in light of feedback from BMS and Novartis

The European Medicines Agency (EMA) has finalized a qualification opinion about the Simcyp physiological based pharmacokinetic (PBPK) platform after reviewing feedback from Bristol Myers Squibb and Novartis.

Researchers use the platform to predict the average magnitude of interactions mediated by enzymes that are involved in the metabolism of drugs. In a draft opinion published earlier this year, EMA said the software can be referenced in regulatory submissions in certain contexts when used per good practice recommendations.

BMS and Novartis independently provided feedback on the draft opinion. EMA made no changes in response to many comments from the companies on the grounds that the qualification is intended to characterize the software in specific circumstances, rather than serve as a comprehensive regulatory guidance or a good practice document for PBPK modeling in drug-drug interaction (DDI) predictions.

“Consequently, while several comments are highly relevant to the broader application of PBPK in DDI prediction, they fall outside the actionable scope of this qualification document,” EMA said. “Such topics may be considered in future qualification procedures or addressed on a case-by-case basis during regulatory submissions.”

EMA made tweaks to the draft opinion in response to other pieces of feedback from the companies but the vast majority of the text, including the key conclusion about the qualification of the platform, is unchanged in the final version.

EMA Opinion, Industry Feedback

European Commission opens consultation into proposed Biotech Act

The European Commission is holding a public consultation into a planned law intended to accelerate the transition of biotech products from laboratory to factory and to the market.

Officials held a call for evidence related to the proposed Biotech Act earlier this year and received 225 responses. Now, the Commission has published a questionnaire to gather feedback from all relevant sectors of biotechnology and biomanufacturing, including the medical and pharmaceutical industries. The feedback will inform attempts to address the challenges faced by European companies.

The Commission wants to know whether people believe EU rules lead to regulatory barriers that hurt efforts to bring biotechnology and biomanufacturing products to market. For each stage from preclinical development to post-market activities, respondents will say to what extent they agree there are barriers, using a scale that runs from strongly disagree to strongly agree.

Officials have provided free text boxes for respondents to provide their views on whether EU rules cause regulatory barriers in other phases of the innovation and manufacturing cycle and to provide evidence of the challenges created by the EU regulatory environment. The Commission has also asked what actions the EU can take to improve the regulatory environment for biotechnology and biomanufacturing.

Another section covers how the EU regulatory environment compares to biotech frameworks in other countries. The Commission wants to know whether people believe the EU or other countries are more predictable and less complex, as well as whether their frameworks lead to lower costs and shorter times to market.

EU Consultation

Other News:

MHRA has published guidance on reporting adverse events linked to digital mental health technologies. The guidance provides examples of digital health adverse events such as artificial intelligence-powered therapy chatbots that enable suicidal thoughts or delusions and virtual reality technical failures that lead to negative psychological effects. MHRA Guidance

MedTech Europe said it is “deeply concerned” that a 15% tariff rate may apply to certain European medical technology exports to the US. The framework agreed by the EU and US applies a 15% tariff to many products. MedTech Europe said it is assessing the implications of the agreement and waiting for further details. Press Release

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has shared a technical recommendation in response to problems with the supply of clarithromycin. The document contains technical considerations for making unlicensed pharmaceutical preparations containing the antibiotic. EDQM said licensed medicines should be used when possible. EDQM Notice

Euro Roundup: UK aims to speed market access by 6 months by coordinating MHRA, NICE reviews

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