Euro Roundup: Swissmedic seeks feedback on ICH real-world drug safety data guidance

The Swiss Agency for Therapeutic Products (Swissmedic) is consulting on a guideline for planning, designing, and analyzing pharmacoepidemiological studies that use real-world data (RWD) to assess drug safety.

The International Council for Harmonisation (ICH) drafted the M14 guideline to provide recommendations and high-level best practices intended to streamline the development and regulatory assessment of study protocols and reports while delivering results accepted across health authorities.

There are no ICH guidelines “that focus on how to generate fit-for-purpose real-world evidence,” despite a rise in the number of pharmacoepidemiological studies that use RWD in a regulatory context globally, according to Swissmedic.

“Although many regions have published guidelines relating to general principles of planning and designing such studies, mainly for the purpose of drug, vaccine and other biologic safety assessments, a lack of harmonization in this area can cause challenges for sponsors and regulators,” Swissmedic continued.

M14 could address the guidance gap for drug, vaccine and other biologic product safety assessments. The guideline is intended to help define the research question, data source selection or generation, and study design. Other sections evaluate whether a data source is fit for purpose, adopt methods to address confounding and bias, and select the format and content of the report.

The consultation follows the publication of the draft guideline for review in other parts of the world. The European Medicines Agency (EMA) began a consultation in June, and the US Food and Drug Administration requested feedback on the text earlier in July. Consultations are also underway in Brazil, China, Korea and Japan.

Swissmedic is accepting feedback on the draft until 30 August. Once the consultation phase is complete, the ICH working group will discuss responses received around the world and update the text as needed. ICH anticipates finalization of the document for implementation in local regulatory systems in May 2025.

Swissmedic Notice

EC updates roadmap for rolling out Eudamed database modules

The European Commission has provided an updated roadmap for the Eudamed medical device database, providing a closer look at the revised timeline for the anticipated adoption of its various features.

Last year, the Commission published a roadmap to have all the modules, which cover topics such as certificates and vigilance, ready for mandatory use in the fourth quarter of 2027. The database is part of implementing the regulations on medical devices and in vitro diagnostics (MDR/IVDR). After publishing the previous roadmap, the European Union updated the Eudamed sections of MDR and IVDR.

Rather than deferring mandatory use of the device database until the last of the modules is completed, the EU will now gradually roll out new features as they become available. The updated timeline reflects the new, accelerated plan for bringing the modules online, starting with those that cover actors, devices, notified bodies and certificates, and market surveillance.

The first milestone is October 2024, when the Commission aims to deliver the end user complete technical documentation for machine-to-machine data exchange for the first five modules. Around the same time, the Commission has scheduled a minimum viable product audit of the first five modules.

Running the audit will position the EU to publish notices about the most advanced modules in its official journal in July 2025 to make use mandatory at the start of 2026. A notice for the vigilance module is scheduled for January 2026, with mandatory use to follow later in the year.

The Commission expects devices to be registered in Eudamed in July 2026, when the transition period for getting products in the system will end. Previously, the Commission envisaged a six-month transition to mandatory use of most modules, ending in the fourth quarter of 2027, and another 18 months before device and certificate registration became mandatory.

Updated Roadmap

EU publishes regulation on quality and safety standards for substances of human origin

The EU has published a new regulation on quality and safety standards for substances of human origin (SoHO) intended for human application.

In the regulation adopted by the Council and approved by the Parliament earlier this year, the EU sets out rules to support the provision of SoHO therapies based on high safety and quality standards and up-to-date technical rules. The regulation is intended to improve harmonization across the EU, facilitate cross-border exchange of SoHO and improve patient access to therapies.

“If not performed correctly and in a consistent manner, processing steps carry risks of contamination or of changing the inherent properties of SoHO in a manner that might reduce their effectiveness,” the regulation states. “Therefore, processing of SoHO should be considered as a SoHO activity and any entity performing SoHO processing should be subject to appropriate oversight.”

With some exceptions, the regulation is set to come into force in August 2027. The Commission will adopt certain articles of the regulation in August 2024 and August 2028. The establishment of penalties by member states is among the articles with the August 2028 deadline.

EU Regulation

Commission asks EMA to re-assess Aplidin application after revoking decision

The EC has asked EMA to re-assess an application for marketing authorization of the cancer drug Aplidin (plitidepsin).

PharmaMar filed for approval of the molecule in 2016 but had the application rejected two years later. The company claimed a conflict of interest on the committee that issued the negative opinion, noting the “Swedish nationalities and Karolinska Institute training” of four members. PharmaMar said the Swedish biotech and Karolinska Institute spinout XNK Therapeutics is a competitor.

After a series of legal hearings, the EC revoked in June its decision to refuse marketing authorization for Aplidin. The revocation led the Commission to ask EMA to reassess the application. EMA said it is “currently taking the appropriate steps to implement this decision.”

The Commission revoked its decision considering a judgment by the Court of Justice, which ruled in March that applying EMA rules on competing interests “could be incompatible with the principle of objective impartiality” in specific circumstances. The court outlined a situation that “would give rise to a legitimate doubt as to the existence of possible bias.”

EMA Notice

EMA elects Ulla Wändel Liminga as next PRAC chair

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has elected Ulla Wändel Liminga as its next chair.

Wändel Liminga, a pharmacist by training, is the scientific director of pharmacovigilance at the Swedish Medical Products Agency and has been one of Sweden’s PRAC delegates since the committee was established in 2012. According to a statement from EMA, Wändel Liminga is a specialist in pharmacology, toxicology, and pharmacovigilance with extensive experience in the EU’s regulatory system.

Wändel Liminga will take up the position for an initial three-year term in September to fill the vacancy created by Sabine Straus, who is stepping down after completing the maximum period allowed in the role.

EMA Notice

Other news:

The European Drug Shortages Formulary Working Party has shared an expert opinion on the shortage of amoxicillin products for children. EDQM Notice

Euro Roundup: Swissmedic seeks feedback on ICH real-world drug safety data guidance

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