Euro Roundup: Commission acts to streamline lifecycle management of medicines

The European Commission has published guidelines intended to give companies more flexibility when modifying and updating their marketing authorizations.

To support a variation regulation that came into force in January, the Commission worked with national regulators and the European Medicines Agency (EMA) on measures for better lifecycle management. The resulting document represents an attempt to implement a simpler, risk-based approach that facilitates quicker and more efficient processing of variations.

The guidelines provide additional information about changes adopted through the revised regulations, such as revisions to the use of grouping, super-grouping and annual reports to submit type IA variations. Rather than submit a notification for each type IA variation, companies can pool notices in various ways.

“The holder may submit several minor variations of type IA for the same marketing authorization under a single notification,” the Commission said. “For purely national procedures, such a notification may also cover one or several identical minor variations of type IA for several marketing authorizations granted in the same Member State.”

Without acceptance from the relevant authorities, the grouping of type IA variations that do not require immediate notification may only be done within the context of an annual update. Another section of the guidelines addresses annual updates.

Super-grouping covers the collection of type IA minor variations for several marketing authorizations into a single submission. The option is available to companies dealing with four sets of minor variations that are described in the guidelines. The Commission said officials may identify additional sets of variations that are eligible for super-grouping as they gain experience with the process.

Other changes implemented through the variation regulation include the elimination of the default type II classification for quality and manufacturing changes for biological products. Under the new risk-based model, some changes to quality control testing arrangements, manufacturing processes, and other aspects of active substance, starting material, and intermediate production fall into type IA and type IB.

The guidelines feature a table to show how various changes are classified under various conditions. For example, the addition or replacement of a batch control or testing site for a biological active substance starting material is a type IA variation, provided method transfer to the new site has been successfully completed and the analytical procedure is not a biological, immunological, or immunochemical.

The guidelines will apply to variation applications submitted to EMA from 15 January 2026. EMA plans to publish updated and new procedural guidance to help authorization holders by the end of 2025.

Press Release, EMA Notice, Variation Guidelines

MedTech Europe leads call for EU to provide regulatory relief by early 2026

MedTech Europe has joined with 35 national associations to call for the European Commission to act to address certain regulatory problems by the end of 2025 or early 2026.

Officials are currently seeking evidence to inform changes to the medical device and in vitro diagnostic regulations (MDR/IVDR). The changes are intended to simplify and streamline the regulatory framework while making it more cost-efficient and proportionate. MedTech Europe and the other signatories of the open letter welcomed the planned legislative reforms but also see a need for more urgent action.

The trade groups want the European Union to work on near-term relief measures in parallel to legislative reform. Specifically, the authors of the open letter are calling for an implementing act that harmonizes rules for notified bodies, pilots on regulatory pathways for orphan, pediatric, and breakthrough devices, and a targeted postponement of re-certification requirements for certain products.

By harmonizing the rules for notified bodies, MedTech Europe said the EU can set maximum assessment timelines, define the scope of changes to be notified, remove duplication of vigilance review, enable early talks with manufacturers that set clinical expectations, and mitigate the burden of re-certification.

The call for the postponement of re-certification requirements covers devices that are already certified under the medical technology regulations. MedTech Europe said the postponement is needed to “avoid a new major bottleneck for devices transitioning to medical devices rules by 2028, and to keep devices available.”

In the longer term, the trade groups want the EU to amend both MDR and IVDR, taking the specifics of each sector into account, and establish “a single and accountable governance structure” to oversee notified bodies. MedTech Europe views notified bodies as essential and a core pillar of the future regulatory framework but sees a need for a body to oversee the sector and the CE-marking system.

Open Letter

EMA sets 5-year target for accelerating initiation of clinical trial enrollment

EMA and other bodies have set five-year targets to evaluate their attempts to make the EU a more attractive destination for clinical research.

In five years, EMA is aiming to ensure that two-thirds of clinical trials begin recruiting patients within 200 calendar days of the date of application submission. Currently, half of clinical trials start enrollment in that timeframe. The UK is aiming to reduce trial startup times from 250 days to 150 days, a target that will require studies to enroll patients within 90 days of regulatory approval or site selection.

EMA, which created its targets with the European Commission and the Heads of Medicines Agencies, is also aiming to grow the number of multinational trials run in the EU. The goal is to add 500 multinational trials to the current average of 900 that are already authorized each year.

The targets will enable officials to monitor the progress of the Accelerating Clinical Trials in the EU (ACT EU) initiative, which is working to optimize how studies are run. ACT EU plans to start publishing monthly progress updates on its website in February 2026.

EMA Notice

Medicines for Europe voices shock at ‘concerted efforts’ to water down CMA

Medicines for Europe has expressed shock at the “concerted efforts” of some Member States to water down the Critical Medicines Act (CMA).

Recent debates at European Parliament committees have exposed concerns about CMA, including claims that the legislation may violate national competence. Medicines for Europe, which represents off-patent drugmakers, pushed back against the claims, arguing that CMA “would only require Member States to fully comply with existing legal obligations” and pleading with the European Council to rethink its stance.

The trade group said the legislation must ensure that demand side measures support viable investments in manufacturing and supply chain resilience while also supporting critical generic producers through substantial EU funding and new state aid flexibilities.

Press Release

Trade groups call for EU to expand use of electronic medical device instructions

Three trade groups have proposed expanding the allowance of electronic instructions for use (eIFU) to cover certain medical devices used by lay people.

MedTech Europe, Eurom, and EuromContact said eIFUs could be used when healthcare professionals provide guidance during the first use of a device and when a product is used repeatedly. Initial guidance could ensure people understand how to use the device correctly from the beginning and repeated use of a product could enable users to become more comfortable and proficient through practice.

The groups cited contact lenses, urinary catheters, and diabetes management products as examples of devices that meet their criteria for eIFU provision. Offering eIFUs with such devices could make health information more accessible and reduce the environmental impact of the products, the groups said.

Press Release

Euro Roundup: Commission acts to streamline lifecycle management of medicines

Related topics

Recommended content

Welcome to the new RAPS Digital Experience