Euro Roundup: EMA urges sponsors to start CTIS switch soon

The European Medicines Agency (EMA) is strongly advising sponsors to submit their applications to the Clinical Trials Information System (CTIS) as soon as possible.

At a recent meeting of its management board, EMA said sponsors have moved 20% of clinical trials to the new platform. The three-year transition period, which began when the Clinical Trials Regulation became applicable, will end on 30 January 2025. Because the authorization process can take up to three months, EMA wants sponsors to start soon to ensure trials are on CTIS by the deadline.

Sponsors that are applying to start clinical trials have needed to submit via CTIS since 31 January 2023. The 2025 deadline applies to clinical trials that began before that date. If a study is ongoing as of the end of the transition period, the sponsor must have moved the trial over to the CTIS.

Last year, EMA adopted revised transparency rules for CTIS, removing a deferral mechanism that allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of a trial. The agency made other changes to benefit sponsors, for example by simplifying the processes for protecting commercially confidential information and personal data.

The Commission “acknowledged the important modernization and simplification work of EMA on CTIS to allow an efficient use of the platform by Member States and sponsors” at the recent meeting, according to the agency. Officials continue to aim to apply the new rules after their technical implementation in CTIS, an event that EMA said would be finalized in the second quarter of 2024 when it made the changes last year.

EMA provided an update on the move to CTIS at a meeting that also covered the new Health Technology Assessment Regulation, which entered into force in January 2022 and has a three-year transition. As the EMA said during the meeting, officials are using the transition to work with the European Commission, the Member State Coordination Group on HTA and industry on the implementation of the regulation.

Press Release

European Commission requests scientific opinion on classification of brain stimulators

The European Commission has asked an advisory committee for a scientific opinion on the risks to health posed by brain stimulators without an intended medical purpose.

The Medical Device Regulation (MDR) describes the devices as equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain. In 2022, six member states asked that such devices to be moved from class I to class III. The request was informed by evidence generated after the adoption of MDR.

Later, the Commission adopted an implementing regulation on the reclassification of groups of certain active products without an intended medical purpose. The regulation reclassified brain stimulators as class III devices. The Commission sought public feedback and consulted the Medical Device Coordination Group to inform the reclassification.

Now, the Commission has asked the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to produce a scientific opinion on the risks the brain stimulators pose to users. The committee will consider evidence generated after the publication of MDR in April 2017.

The Commission wants SCHEER to identify any hazards and risks, look at the potential for permanent modifications of the structure or functioning of the brain, and “determine if and under what conditions the administration of energy to the human body is made in a potentially hazardous way.” SCHEER has until the end of 2025 to adopt a final scientific opinion.

Commission Request

EMA answers question on contact with patient and healthcare groups in updated Q&A

EMA has updated its question-and-answer document on pre-authorization procedural advice for users of the centralized procedure, adding a new question on early contact with patient and healthcare groups and revising its responses to some existing queries.

In its new answer, EMA explains that the Committee for Medicinal Products for Human Use piloted a method of engaging with patient organizations at the start of the evaluation of new applications for authorization of orphan medicines in 2021 and 2022. The pilot had a successful outcome.

“As part of the continued implementation of this methodology, it was agreed to expand the selection of medicines from orphan medicines to include also non-orphan ones and to reach out to healthcare professional organizations in addition to patient organizations. Input received from these organizations is shared with the Rapporteurs and with the Applicant for transparency,” EMA wrote in the Q&A.

In updating its responses to existing queries, EMA added information about the structure of interactions with applicants before they file for authorization. The updated response says EMA may “comment if it is felt that the application is ‘premature’ and might benefit by including data from ongoing/additional studies prior to the application being submitted.”

Another updated response addresses the manufacturing information applicants should include in their submissions. EMA has clarified that applicants should include details of “any contract manufacturing sites or contract testing laboratories for API or finished product.” The updated response also addresses reliance on inspections by agencies that have mutual recognition agreements with EMA.

EMA Q&A

Commission designates first six European reference laboratories for public health

The European Commission has designated the first six European reference laboratories (EURLs) for public health as part of its push to strengthen the region’s defenses against serious cross-border threats.

Under the regulation on serious cross-border threats that lawmakers adopted in 2022, the EU is setting up a network of EURLs “to support monitoring of disease outbreaks that are relevant to substances of human origin.” The goal is to pool scientific expertise across the EU to improve preparedness, detection and response.

The first set of EURLs cover antimicrobial resistance in bacteria, vector-borne viral pathogens, emerging, rodent-borne and zoonotic viral pathogens, high-risk, emerging and zoonotic bacterial pathogens, legionella, diphtheria and pertussis.

“These EURLs will support national public health laboratories by ensuring data comparability and capacity strengthening on laboratory methods at the EU level. This includes efforts to align on diagnostics and testing for surveillance, notification and reporting of diseases,” the Commission wrote.

The EURLs are designated for seven years and funded under the EU4Health program. The EU is cutting the budget of the program by around 20% to free up money for Ukraine, leading the Commissioner for Health and Food Safety to warn there will be difficult decisions about which health activities to fund.

Press Release

Other news

EMA’s adjusted fees will come into effect on 1 April 2024. The agency has used the 3.4% inflation rate as its reference point for the resetting of fees. EMA is retaining the current fees for pharmacovigilance this year in anticipation of new legislation on fees coming into effect at the start of next year. The new fee legislation includes an annual pharmacovigilance levy on authorization holders. EMA Notice

The European Commission has begun investigating potential breaches of competition rules by Zoetis, an animal health company that sells the only monoclonal antibody medicine approved in Europe to treat pain associated with osteoarthritis in dogs. The investigation centers on Zoetis’ acquisition of a late-stage pain relief candidate. Zoetis ended development and is “refusing to transfer” the asset. Press Release

Euro Roundup: EMA urges sponsors to start CTIS switch soon

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