EMA updates SME guide to reflect clinical trial reporting requirements

The European Medicines Agency (EMA) has updated its user guide for small and medium enterprises (SME) based on new requirements coming into effect under the EU Medical Devices Regulation (MDR). It touches on issues such as clinical trial requirements, use of the agency’s IT systems, addresses products with regulatory framework uncertainty, and more.

On 23 January, EMA republished its user guide for SME’s that updated sections based on new requirements under MDR. The guide is specifically catered to SMEs that may not have the resources of larger companies to specialize in EMA regulations and emphasizes requirements that are specific to their needs.

The biggest update to the document addresses clinical trial regulations and the agency’s Clinical Trials Information System (CTIS). EMA notes that previously, sponsors were required to submit clinical trial information separately to countries in the EU or European Economic Area (EEA), but now they can transition to the CTIS, where individual countries can retrieve the information, which will be phased in over the next few years.

EMA said it foresees a three-year transition period to implement CTIS requirements under the 2014 Clinical Trials Regulation. The agency has already required sponsors to submit initial clinical trial applications, starting last year. Now, it says all ongoing trials that were approved under the Clinical Trials Directive before 31 January 2023 will have to transition their data to CTIS and conform to the new regulation by 31 January 2025.

“Under the Clinical Trial Regulation, the authorization and oversight of clinical trials remains the responsibility of the EU/EEA member states,” said EMA. “EMA is responsible for the maintenance of CTIS and the European Commission ensures oversight and control of the implementation of the Clinical Trials Regulation.”

The user guide includes updated requirements sponsors need to adhere to under MDR. More specifically, EMA clarifies what is considered a medical device or in vitro diagnostic and how they are treated under the regulation.

The guide also details what sponsors must do based on their product's risk-level. For instance, it states that sponsors of high-risk medical devices must consult specific expert panels to get an opinion on the notified body’s clinical assessment under the clinical evaluation consultation procedure (CECP). Similarly, class D in vitro diagnostics need to undergo a performance evaluation consultation procedure (PECP) to determine the manufacturer’s performance evaluation.

Additionally, EMA notes that the guidance includes new sections and subsections to clarify SME expectations based on the new regulation, such as how to use different IT systems provided by the agency and expectations for products with regulatory framework uncertainty also known as Borderline Products.

"Applicants who are unclear on the correct classification of their product should consult a national competent authority and provide information on the product’s composition and constituents, a scientific explanation of the mode of action and its intended purpose," said EMA. "In case of scientific questions arising for the classification of the product, the EMA’s [Innovation task force (ITF)] can guide medicine developers with scientific views to support development of the borderline products or as applicable further interactions with EMA procedures relating to the research and development of borderline products."

Other changes to the guide include detailing requirements for conducting Environmental Risk Assessments (ERA), using big data in decision-making, using EMA’s EU-M4all process for high priority drugs for patients outside the EU, and the agency’s opening procedures at EMA to non‑EU authorities (OPEN) initiative to evaluate certain drugs in collaboration with the World Health Organization (WHO).

In addition to the user guide, EMA also published an annex that includes information on individual EU and EEA regulators that sponsors can contact for further information.

Updated SME user guide and annex

EMA updates SME guide to reflect clinical trial reporting requirements

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