Euro Roundup: EFPIA calls on EU to support EMA AI spending, upskilling in 2028-2034 funding plan

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its wish list for the next European Union Multiannual Financial Framework (MFF), which will shape the region’s budget from 2028 to 2034.

EFPIA sees the framework as a chance to align spending with the push to make the EU more competitive. The MFF should “ensure the competitiveness of the EU regulatory system and foster the development and conduct of multi-country clinical trials,” the trade group said. EFPIA framed healthcare spending as a part of plans for defense, an area that is likely to receive particular attention in light of global events.

The trade group shared specific recommendations on regulatory spending. EFPIA wants the EU to match the “ambitious reforms” set out in the pharma legislation with “resources for the European Medicines Agency [EMA] and regulatory network to ensure that the EU's regulatory system maintains its global competitiveness and that resource constraints are not a blocker for new initiatives.”

Officials should ensure the next MFF includes enough money for activities that are not service related, and therefore not funded through the fee system, “but are necessary to ensure a well-resourced and future-proof regulatory system,” EFPIA said. The agency identified four areas that fit that description.

EFPIA wants the framework to provide funding for upskilling staff “to cope with advances in science and technology and ensure effective oversight of future innovation.” The trade group is also calling for “greater collaboration with regulators from other countries to align on evidence requirements and to find efficiencies in regulatory oversight activities.”

The final two regulatory recommendations cover spending on advanced analytics and solutions enabling AI experiments and actions to enhance data and technology infrastructure to support the European Medicines Regulatory Network Strategy. EFPIA said the data and technology investment should ensure “seamless regulatory information flow and full participation across countries.”

EFPIA also made recommendations about how to modernize clinical trials, calling for the EU to provide the resources for single approvals of multi-country trials. The request for a new process, which EFPIA said should include combination products, reflects a belief that multi-country and EU-wide studies are “burdensome and time-consuming, due to ongoing regulatory fragmentation and a lack of coordination.”

EFPIA Notice

EMA updates Q&A on drug shortage platform’s submission and reporting requirements

EMA has addressed new questions about drug shortage data submission and reporting requirements in an update to its existing advice on the European Shortages Monitoring Platform (ESMP). The platform allows EMA to gather information about medicine availability, supply and demand to prevent, detect, and manage human medicine shortages in the European Union. Five of the six new questions relate to data submission and reporting.

The agency used the update to clarify that “the information contained in ESMP submissions is not shown in the users’ submission history.” EMA keeps the information private because the person submitting data may be affiliated with multiple marketing authorization holders. A user can see the most recent information about their organization's products, regardless of who uploaded the data, by downloading the submission template for the selected medicines.

EMA answered another question about what users should do if none of the root cause options reflect the driver of their shortage. Users should choose the “Other” option and use the free text field to give EMA the information it needs to assess the shortage. Companies that believe a common shortage cause is missing from the list should contact EMA’s service desk.

The agency clarified that companies notifying shortages related to quality issues should submit a quality defect notification, regardless of whether the batch is on the market yet and discussed how it will use data submitted to the ESMP. EMA said it will use the platform’s shortages monitoring and risk analysis tool to assess supply and demand during crises. The agency will activate the preparedness submission sections of the ESMP home page in a crisis.

EMA also answered a new question about the link between the Union list of critical medicines and the ESMP reporting requirements. There is currently no direct link, EMA said, but there may be overlaps between the Union list and lists drawn up for specific crises.

EMA Q&A, More

EMA seeks public feedback on draft qualification of pharmacokinetic modeling software

EMA has released a draft qualification opinion about the Simcyp physiological based pharmacokinetics (PBPK) platform for consultation.

The opinion covers the use of the PBPK platform to predict the average magnitude of interactions mediated by CYP enzymes in certain contexts. CYP enzymes are involved in the metabolism of drugs. The software supports predictions of the effects of CYP inhibitors and informs assessments of drug-drug interaction risks for new medicinal products.

EMA said when the software is used per good practice recommendations and in the contexts covered by the draft opinion its predictive performance can be referenced in regulatory submissions. The agency is accepting feedback on the draft opinion until 19 June.

Draft Opinion

PRAC moves to minimize risk of suicidal thoughts with 2 drugs after reviewing safety data

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended measures to minimize the risk of suicidal thoughts with finasteride and dutasteride medicines.

PRAC confirmed suicidal thoughts as a side effect of finasteride, a medicine used to treat an enlarged prostate and hair loss due to male hormones. Most cases were seen in people taking a 1mg dose to treat hair loss. The findings informed the decision to add a patient card to finasteride packages to discuss the risks and an update to tell users to seek medical advice if they experience problems with sexual function.

A review of dutasteride, another treatment of enlarged prostate, was unable to establish a link between the drug and suicidal thoughts. However, dutasteride works the same way as finasteride. The similarities between the drugs led PRAC to add details of the mood changes seen with finasteride to dutasteride’s product information as a precaution.

Press Release, More

EFPIA analyzes drivers of delays to drug reimbursement in the European Union

EFPIA has published reports on the drivers of variability in the time it takes to get new medicines to patients in countries in the European Union.

The EU pharmaceutical reforms will grant drugmakers another two years of regulatory data protection if they make their medicines available in all member states within a certain period of time after approval. EFPIA has argued that forces beyond the control of companies delay market access in parts of the EU and called for actions that address issues it believes are the root causes of the situation.

The trade group’s analysis of 94 medicines approved between January 2021 and June 2024 found 69% of delays happened after a company filed and was waiting for a decision from a member state. EFPIA also looked at the drivers of delays in smaller countries, which typically wait longer for medicines, and found issues such as a lack of resources and inconsistent application of assessment criteria set back decisions.

Press Release

Other News:

MedTech Europe has called for the EU to integrate real-world evidence into regulatory frameworks and reimbursement decision-making processes to support adoption of robotic-assisted surgery. Report

Euro Roundup: EFPIA calls on EU to support EMA AI spending, upskilling in 2028-2034 funding plan

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