Regulators explain process for requesting real-world evidence studies by EMA

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have released a new guideline outlining the steps involved for EU stakeholders, including national competent authorities, scientific committees, and other partners to request EMA conduct real-world evidence (RWE) studies to inform regulatory decision-making.

The document explains that when considering such requests, EMA will first consider whether the study is feasible using the Data Analysis and Real-World Interrogation Network DARWIN EU database, which went into effect earlier this year. The document also provides an overview of the types of RWE studies and how they can be used to support regulatory decision making.

EMA currently has access to a variety of data sources that can be used to generate RWE, including DARWIN EU, in-house electronic data base from various European countries, and through the agency’s framework contracts with external research and academic institutions. EMA will prioritize Darwin EU when evaluating the feasibility of a requested study, as the database has aggregated RWD from databases across the EU on diseases, populations, and drug performance.

“As of February 2024, DARWIN EU has entered full operation mode and has become EMA’s primary RWE generation pathway,” said HMA. “This means that for any research question, DARWIN EU will be considered first when exploring if a study is feasible.”

The guideline states that when feasibility assessments are conducted, data reliability from EMA partners in Darwin EU is already considered. However, the DARWIN EU Coordination Centre will still follow up with its partners to find relevant data that can help answer RWE research questions. Based on the coordination center and the requestor’s proposal, EMA will decide whether the available data is fit for purpose. They will also consider whether the time required to conduct the study is feasible.

If EMA decides that using DARWIN EU is not feasible, it will look to other sources of information to conduct the RWE study.

“EMA has currently access to several databases consisting of primary care health records from different countries in Europe, including primary care with specialist health records,” said HMA. “To increase access to data obtained from specialized settings, EMA is currently working on accessing also specific hospital prescribing data (date to be confirmed). These datasets can be interrogated to provide quick turnaround answers to simple questions or support more complex studies.”

The guideline also stated that EMA has contracts with eight research organizations and academic institutions that can conduct studies on its behalf that it may consider using for RWE studies if the other options are not viable. In such cases, the agency could use 59 data sources from 21 EU countries and leverage the research expertise of the contracted institutions.

Stakeholders can ask for an RWE study to be conducted when researchers are trying to answer questions linked to a procedure that are identified when preparing or commenting on assessment reports or when discussing the matter with a scientific committee. These questions may also arise outside the scope of a specific regulatory procedure when researchers expect more evidence to be generated and for non-product-specific questions.

Regulators explain process for requesting real-world evidence studies by EMA

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