Euro Roundup: EMA, HMA recommend regulatory changes to address radiopharmaceutical challenges

European authorities have recommended changes to the regulatory framework to keep pace with the progress of the radiopharmaceutical sector.

Radiopharmaceuticals’ use of radioactive materials to treat and diagnose disease sets them apart from other drug modalities, giving the products unique characteristics that must be reflected in the regulatory framework and scientific guidelines. The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) discussed the modality and its regulatory requirements in a horizon scanning report.

EMA and HMA concluded that the compartmentalization of European legislation on pharmaceuticals and on radiation protection creates challenges. The laws need aligning, for example in terms of terminology and on the need for a dosimetry-based treatment for all patients, the agencies said.

Reflecting those challenges, EMA and HMA flagged an opportunity to provide guidance on implementing the radiation protection legislation and on its interdependencies with the pharmaceutical laws. Creating such guidance could ensure both regulatory areas are respected, the agencies said.

The agencies identified an opportunity to improve dialogue and cooperation with radiation protection authorities. EMA and HMA recommended exploring the creation of a working group with EU medicines agencies and radiological protection regulators to align guidance on radiation safety and pharmaceutical regulations in the EU. International knowledge sharing and harmonization is another objective.

A lack of harmonization in the interpretation and implementation of EU radiopharmaceutical regulations across Member States was the other main regulatory challenge identified by the agencies. The problem affects small-scale production of radiopharmaceuticals.

Radiopharmaceuticals “can be administered as magistral preparations, officinal preparations, or via the compassionate use route depending on the EU Member State,” the agencies said. These legal routes lead to radiopharmaceuticals being made using nonauthorized kits, generators, and radionuclide precursors, and to various degrees of compliance with good manufacturing practices (GMPs) across Member States.

EMA and HMA see a chance to continue working to harmonize the regulation of small-scale preparations and the implementation of GMPs, with a particular focus on PET radiopharmaceuticals. The report’s authors listed creating an EU-wide working group focused on the topics among the actions authorities should consider.

Other suggestions include revising guidelines to ensure Member States perform consistent assessments of the products and to provide guidance on implementing the radiation protection law. New guidance on diagnostic radiopharmaceuticals is needed because of recent scientific developments, the agencies said.

EMA-HMA Report

Notified bodies warn against uniform reduction in preventive MDR and IVDR safeguards

Notified body association Team-NB has warned against the uniform reduction of preventive regulatory safeguards in its feedback on planned changes to the medtech regulations.

In December, the European Commission proposed reducing and simplifying the rules on medical devices and in vitro diagnostics. The proposals reflected a belief that the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have underlying structural problems that affect the availability of devices and the competitiveness of EU manufacturers.

Seeking a lasting solution for the repeatedly delayed regulations, the Commission proposed changes to simplify the rules, cut administrative burdens, and make certification by notified bodies more predictable and cost-effective. Notified bodies worry the changes go too far.

In a 95-page response to the proposals, Team-NB said “efficiency gains must not be achieved through uniform reduction of preventive regulatory safeguards.” The association concluded that “preventive controls, particularly in early and late lifecycle phases, remain essential and cannot be replaced solely by reactive, ‘for‑cause’ mechanisms.”

The conclusion reflects the belief that the proposal shifts the EU “from a proactive, preventive framework to a predominantly reactive one, where issues are identified only after serious incidents or widespread complaints arise.” Team-NB said the shift would undermine the intent of MDR and IVDR and increase the likelihood that unsafe or non‑compliant devices remain in clinical use.

If the Commission provides regulatory relief, including by reducing oversight and administrative burdens, the actions “should be earned, justified, time‑limited and reversible, based on demonstrated compliance performance,” Team-NB said.

Other Team-NB recommendations include strengthening governance structures through clearer roles, improved coordination, and procedural support at the EU level. Team-NB said those changes must avoid “diluting regulatory accountability.” The association also recommended “clear, restrictive, and legally predictable frameworks” for clinical evaluation pathways, including for well‑established technologies.

Team-NB Notice

EMA answers more than 150 sponsor questions about Clinical Trial Information System

EMA has answered frequently asked questions about using the Clinical Trial Information System (CTIS) across the study lifecycle.

The document features more than 150 questions about pre-submission steps, applying to run a study, the evaluation stage, conducting trials, and submitting results. Officials focused the document on the parts of the trial lifecycle with the most frequently asked questions.

EMA clarified that sponsors must enter information on a drug candidate in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) even if another sponsor has already done so. The system assigns a different product number for each sponsor and lacks automatic linking between entries. Another query covers changes EMA implemented in February to allow people on Mac computers to access XEVMPD.

Other sections of the document explain that sponsors cannot change trial categories using a substantial modification after the initial trial application is authorized. EMA may accept a category change if the sponsor explicitly requests the revision in a request for information issued during the initial application.

EMA FAQ

UK MHRA works with eBay to remove 215 listings of potentially dangerous medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) and eBay have removed 215 listings of potentially dangerous medicines.

As part of its long-standing relationship with the eCommerce platform, the UK regulatory agency found listings selling unauthorized erectile dysfunction medicines for removal by eBay. MHRA said the shape of the tablets indicated that they were fake. The agency team that classifies borderline products confirmed that the products were not genuine.

MHRA alerted eBay about the products, leading the company to immediately remove the listings from its platform. The agency is unsure what the products contained. Other analyses have found unauthorized products can contain no active ingredient, too much active ingredient, or toxic ingredients. Last year, eBay introduced an AI tool for identifying and blocking listings that violate its policy on medicine sales.

Press Release

EMA schedules meeting to hear industry’s view on breakthrough medical device pilot

EMA has arranged an online information session for 24 April to discuss the breakthrough medical device program it plans to pilot this year.

Officials plan to start the pilot in the second quarter to support development of highly innovative devices and in vitro diagnostics. Companies with eligible devices will receive enhanced regulatory support and priority scientific advice from the medical device expert panels. Trade group MedTech Europe has called for EMA to establish a breakthrough program.

The agenda for next week’s meeting includes time allocated for the European Commission’s perspective and expectations and the industry’s perspectives on the practical implications of the program. Other topics on the agenda for the two-hour meeting include the role of expert panels in the breakthrough devices framework and notified body’s activities and responsibilities.

Press Release, Meeting Agenda

Other News:

MHRA has approved Novo Nordisk’s 7.2mg Wegovy pen to treat adults with obesity. The approval of the pen follows the January authorization of a 7.2mg maximum weekly dose of the GLP-1 receptor agonist. Before this week’s approval, patients needed to use three 2.4mg pens on the same day to achieve the maximum authorized dose. Press Release