Euro Roundup: EMA outlines steps for improving clinical trial coordination in public health emergencies

The European Medicines Agency (EMA) has published a summary of its workshop on lessons learned on clinical trials in public health emergencies, providing an overview of how it plans to revise its regulations and framework ahead of the next crisis.

Last month, EMA’s Emergency Task Force and the European Commission met with national competent authorities, ethics committee representatives, and academic sponsors to review the current processes during health emergencies, explore ways to accelerate approval of multinational studies, and define a framework capable of fostering larger multinational clinical trials.

This week, EMA published its takeaways from the workshop. The event generated proposals focused on two areas: the processing and regulatory approval of large, multinational studies; and the framework for funding and efficient allocation of resources for clinical trials.

In terms of processing and regulatory approval, attendees discussed how to improve coordination between regulators and ethic committees within and across member states, speed up assessment and authorization of clinical trial applications, explore flexibilities in the implementation of the Clinical Trials Regulation (CTR) and facilitate the use of the EU Clinical Trials Information System.

Attendees criticized CTR, with EMA reporting that they have found the submission and assessment process for multinational filings to be “burdensome and slow mostly due to the necessity of alignment of national laws.” The attendees also highlighted flexibilities, though, noting that the regulation “does not prevent collaborative approaches on a voluntary basis outside of CTR to accelerate scientific, ethical, and procedural aspects during public health emergencies.”

EMA’s summary of the discussion includes several proposed actions, including acting to ensure that no additional information can be requested on top of CTR requirements and the creation of an emergency application package that minimizes the need to gather documents while still complying with the clinical trial regulation.

Attendees agreed that there is a “need to reconsider the implementation of the CTR with enhanced flexibility in mind to avoid bureaucracy, and bottlenecks.” The work to improve the implementation of the regulation “should include a simplified template and process for providing a final assessment report.”

To address the slow assessment and authorization of clinical trial applications, the attendees proposed setting up “an EU-level cooperation mechanism between national ethics committees,” enabling sponsors to request pre-submission consultations on specific applications and establishing a “one-stop shop forum to coordinate discussions and advice.”

EMA and its collaborators will now work to establish “a concrete roadmap for improved clinical trials during public health emergencies in the EU.” The Accelerating Clinical Trials in the EU initiative will take on tasks related to the approval of studies in public health emergencies.

Press Release, Workshop Report

MHRA presents plan to improve performance after missing multiple targets in past year

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has outlined how it plans to improve its performance after a financial year in which it missed multiple regulatory timeline targets.

MHRA’s monthly updates have shown that the times taken to process certain submissions have grown (RELATED: Euro Roundup: Swissmedic updates guidance on combined clinical trials to test drugs, devices, Regulatory Focus, 19 April 2023). Last week, the agency brought all the figures together in its annual report, which covered the period from 1 April 2022 to 31 March 2023. The figures show MHRA missed multiple targets, in some cases by a wide margin.

Across its 2022 to 2023 financial year, MHRA assessed 25.9% of clinical trial applications within 30 days of submission. The target was 98%. In the previous financial year, MHRA met the deadline 99.6% of the time.

MHRA blamed the missed target on “resourcing challenges” and committed to meeting its timelines by the start of September. The agency has “increased capacity by recruiting and training new staff” and is “clearing backlogs and improving communications to help provide companies with more certainty on the timelines.”

The regulator also missed its targets for the percentage of: medicines assessed via the national route which contain a new active substance within 210 days; medicines assessed via recognition within the published recognition pathway timeline; and established products assessed via the national route within 210 days. The agency met the established product deadline 13% of the time last year.

Annual Report

EMA updates guidance on votes and recommendations by human medicine committees

EMA has revised its guidance on voting in the framework of discussion and adoption of opinions by its scientific committees and the coordination groups for mutual recognition and decentralized procedures.

The document replaces guidance published in 2008 that only applied to the Committee for Medicinal Products for Human Use. EMA has expanded the scope of the guidance to cover all committees and almost completely rewritten the text, including by providing a new, extended set of voting principles and a revised voting process.

Across 11 bullet points, EMA details its voting principles, starting by explaining that a quorum is required for the adoption of an opinion before going on to discuss how the committee chair should try to achieve consensus on a topic before deciding that a formal vote is needed.

“The opinion will be considered adopted if supported by an absolute majority. When absolute majority is not reached at the final vote step, the vote outcome and corresponding committee opinion shall be deemed negative in relation to the matter at stake. No further vote is to be taken,” the guidance states.

EMA Guidance

EMA seeks feedback on plans to update pair of radiopharmaceutical guidance documents

EMA is holding consultations into its plans to revise two radiopharmaceutical guidelines. The draft concept papers discuss plans to change the guideline on radiopharmaceuticals and the guideline on radiopharmaceuticals based on monoclonal antibodies.

The monoclonal antibody guideline dates back to 1991. While the other guideline is more recent, having come into effect in 2009, EMA has determined it needs updating to “deal with recent developments and practices in the field of radiopharmaceuticals” and address shortcoming such as the non-harmonized interpretations and the lack of coverage of some issues.

In response, EMA has begun work to update the two guidelines in parallel. The agency has identified 12 key items for the radiopharmaceutical guideline, including the need for more detailed documentation requirements, and nine areas of focus for the antibody update. EMA is accepting feedback until the end of October and will later hold six-month consultations on the draft guidelines.

Concept Paper, More

European Pharmacopoeia Commission revises position on nitrosamine impurities

The European Pharmacopoeia Commission (EPC) has revised its strategy on the control of N-nitrosamine impurities, switching from providing advice in individual monographs on active substances to discussing the requirements in general documents.

According to the European Directorate for the Quality of Medicines and HealthCare (EDQM), EPC used its meeting last month to discuss whether covering the carcinogenic impurities in individual monographs is the right approach now that N-nitrosamine requirements are outlined in general texts on substances for pharmaceutical use and pharmaceutical preparations.

EPC recommended deleting existing sections on N-nitrosamine impurities from individual monographs, and stopping adding such sections to new monographs, to “avoid unnecessary repetition, ensure inter-monograph consistency and prevent the absence of such a statement in a monograph being misinterpreted as an absence of risk.”

EDQM Notice

Other news:

The European Commission plans to launch a roadmap for reducing and ultimately ending animal testing in the development of human medicines and other settings. Press Release

Euro Roundup: EMA outlines steps for improving clinical trial coordination in public health emergencies

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