Euro Roundup: EMA identifies need to adapt frameworks, processes to accommodate AI

The European medicines regulatory network’s AI Observatory has shared its first annual report alongside a compilation of examples of AI use and a horizon scanning document.

Officials set up the AI Observatory to capture and share experience and trends in AI to inform the work of the European Medicines Regulatory Network. The European Medicines Agency (EMA) published a set of documents from the AI Observatory last week, revealing a need to adapt frameworks and processes to accommodate the use of AI in internal processes.

The adaptation includes implementation of AI tools, guideline updates and efforts to ensure regulatory staff are trained to evaluate AI-driven assessments. EMA is piloting ChatGPT@EMA to boost productivity and has moved AI tools for automating document comparisons and anonymizing data into production.

Companies are discussing AI with regulators too. Most talks in 2024 still covered pre-authorization steps, such as scientific advice, but EMA reported “growing interest in discussing AI throughout the medicine lifecycle.” Applicants are investigating the use of generative AI to support the drafting of regulatory documents, including clinical study reports, EMA said.

EMA Review, Observatory Report, More

UK plans to accelerate trials, access to drugs fall short of industry expectations

The UK government has launched its industrial strategy for life sciences, setting out plans to accelerate clinical trials and access to treatments. Trade group ABPI said the proposals are positive but fall short of what is needed to “reverse the decline of the UK’s standing as a center for life sciences.”

After taking power last year, the new UK government signaled its intent to create industrial plans for eight sectors. The resulting 10-year life sciences strategy is designed to address long-standing barriers to the scaling of businesses and more recent problems with the efficiency of regulatory processes.

“Even in areas of traditional strength such as regulation and clinical trials, the UK has underperformed in recent years, with a slower median time for setting up and approving commercial trials compared to many competitors, and a series of (now addressed) backlogs across medicines approvals,” the UK government said.

In response, the government set out plans to cut bureaucracy and standardize contracts to reduce the set-up time for commercial interventional clinical trials to 150 days by 2026. The changes are expected to double participants in commercial interventional trials by 2026, and again by 2029.

“The government will also create full transparency on performance by publishing a monthly scorecard for the NHS on trust-level clinical trial performance, broken down by commercial and academic trials and between interventional trials and observational studies and expand the UK-wide National Contract Value Review,” officials said.

Other objectives include ensuring UK regulatory and market access systems get innovations to patients quickly. The government plans to “reduce unwarranted barriers to market entry, through faster, risk-proportionate and predictable routes to regulatory approval.”

That will mean investing in the UK Medicines and Healthcare products Regulatory Agency (MHRA) and supporting its digital transformation. From 2026, the government wants MHRA to have digital platforms that better support industry filings and inquiries and use AI where appropriate to accelerate the pace of regulation.

The government also wants to streamline the path to market for medicines and medical devices that are already approved overseas by making more use of international reliance and recognition routes. Officials plan to introduce an international reliance framework to Parliament by fall 2026.

ABPI said the plan includes “many important and necessary commitments” to accelerate the pace and ease of research. However, while positive, the changes fall short of what is needed, according to the trade group. ABPI sees “long-term disinvestment in innovative medicines that is increasingly preventing NHS patients from accessing medications that are available in other countries” as a core problem.

Sector Plan, Press Release, MHRA Notice, ABPI Statement

EFPIA calls for urgent changes to address ‘perilous’ situation for clinical trials

EFPIA has called for the urgent implementation of the European Union’s Life Science Strategy (LSS), warning that the region’s “trial ecosystem faces a perilous situation” that policymakers must address.

The European Commission launched a strategy early this month to make the region a life sciences leader by 2030. Pharma trade group EFPIA and other organizations working in the European clinical trial sector have joined forces to make the case for a speedy implementation of the plan, stressing the urgent need for better regulatory alignment across Member States.

EFPIA said “fragmented implementation” of the Clinical Trials Regulation has created problems. Barriers for clinical studies, inconsistent assessments and complex requirements “continue to delay trial launches and increase the administrative burden,” according to EFPIA.

The groups support the ideas put forward in the LSS but “remain concerned that the speed in which the proposals could be implemented will not be fast enough to mitigate the threat of more clinical trials leaving Europe for other regions of the world.” EFPIA wants policymakers to embrace “streamlined and risk-based approaches, particularly for investigator-initiated, low-intervention and pediatric trials.”

Press Release

EMA shares guidance on bridging requirements for well-established use applications

EMA has clarified the requirements for bridging data to support applications for the approval of active ingredients that have been used for more than 10 years.

The well-established use pathway allows applicants to base marketing authorization submissions for older active ingredients on results from the scientific literature. EMA has updated a question-and-answer document to “facilitate predictable and scientifically robust assessment.” The update explains what data to compare and how to form the bridge, including when similar bioavailability is more or less critical.

EMA said results from the scientific literature are only acceptable when “relevant and sufficient to demonstrate the safety and efficacy profile” in the proposed indication. The scientific literature is unlikely to be sufficient for biologicals because the manufacturing process and the starting materials shape the safety and efficacy profile.

Similarly, while there are no restrictions on dosage forms, EMA said “bridging of products that have modified-release characteristics or which are topical/transdermal formulations may be particularly challenging.” Applicants should either show their product is identical to those studied in the literature or provide adequate bridging data in line with applicable guidelines.

EMA Q&A

EPC concludes monoclonal antibody pilot, plans further public biotherapeutic standards

The European Pharmacopoeia Commission (EPC) has endorsed the conclusion of a pilot project that established monographs for monoclonal antibodies and general chapters on key analytical techniques.

Officials launched the pilot in 2014 to explore the feasibility of developing quality standards for monoclonal antibodies. The pilot delivered monographs for infliximab and adalimumab, antibodies that were respectively sold as Remicade and Humira. The infliximab monograph has been published in the European Pharmacopoeia, as have general chapters on cell-based potency assays and capillary isoelectric focusing.

EPC said the conclusion of the pilot sets the stage for future standardization in the monoclonal antibody field. The working party will continue as a regular Ph. Eur. group and support the development of public standards for multi-source antibodies. Another working party will continue elaborating standards for single-source antibodies.

Press Release

Other News:

EMA’s safety committee has lifted the temporary restriction on using the live attenuated chikungunya vaccine Ixchiq in people aged 65 years and above. However, the committee recommended that, in people of all ages, the vaccine should only be used when there is significant risk of chikungunya infection and after a careful consideration of the benefits and risks. EMA Notice

Euro Roundup: EMA identifies need to adapt frameworks, processes to accommodate AI

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