Euro Roundup: EFPIA, MedTech Europe comment on Commission’s life sciences strategy
Pharma and medtech trade groups are pushing for the structural reform of the medtech sector’s regulatory system and the acceleration of the digital transformation of regulatory systems, as part of their responses to the European Commission’s call for evidence on a new life sciences strategy.The Commission began the consultation after becoming concerned that the EU “has been losing ground to its main global competitors.” In response, officials sketched plans for a new strategy to boost competitiveness, accelerate green and digital transitions, create jobs, and reduce dependencies on external sources.
The industry groups said that regulatory reform is central to the EU’s ability to achieve those goals. Pharma trade group EFPIA made “restoring leadership in clinical research” one of the central planks of its response to the Commission and shared a 13-page proposal focused on the topic. The focus reflects a belief that “regulatory fragmentation and operational complexity” make the EU less attractive.
“Non-legislative changes alone are insufficient to sustain Europe’s long-term competitiveness in clinical research,” EFPIA wrote. They added that while updating the medtech legislation is the most urgent priority, tweaking the Clinical Trials Regulation (CTR) is also needed.
“The CTR has yet to deliver on its full potential,” EFPIA said. “Rather than a full revision, a targeted approach with focused amendments and full implementation across all Member States is needed. These actions must be supported through sufficient resourcing at all levels, particularly to enable efficient coordination and agile decision-making by national authorities.”
EFPIA made more than 10 specific proposals to simplify and improve the clinical trial regulatory system. The industry group wants the EU to streamline clinical trial processes by enabling parallel submissions of substantial and non-substantial modifications and to enhance the efficiency of study assessments and approvals by moving toward product-based trial submissions.
Other proposals include defining and aligning the roles and responsibilities of ethics committees and national competent authorities, and enabling innovative trial designs, methods, and technologies. EFPIA named platform studies, decentralized trials, and digital endpoints among the innovations it wants the EU to encourage.
MedTech Europe called for medical device and in vitro diagnostic regulatory reforms in its submission to the Commission. The industry group put “structural reform to each of the medtech sector’s core regulations” by early 2026 at the top of its list of seven priority areas. MedTech Europe’s second top priority is better alignment and simplification of regulations across domains.
“We believe the strategy should aim to build a more systematic approach to evaluating regulatory impact, including competitiveness checks and retrospective assessments and ensure an efficient interplay between MDR/IVDR and other legislation,” the trade group said. MedTech Europe named data protection, product liability, and artificial intelligence laws as examples of areas of regulatory interplay.
The trade group also called for the EU “to systematically address and debunk environmental, food, packaging and chemical legislation that affects the manufacturing and supply of medical devices in Europe.” MedTech Europe singled out the implementation of the EU Packaging and Battery Regulations as an example of a law that should be fully synchronized with the medtech regulations.
EFPIA Notice, MedTech Europe Notice
Industry feedback shows EMA ways to improve regulatory talks early in development
The European Medicines Agency (EMA) has published industry feedback on how it provides advice early in developing innovative medicines.
A survey of companies that met with groups such as EMA’s Innovation Task Force (ITF) found businesses are generally satisfied with the timing and clarity of the meeting request processes, the information provided, the overall meeting experience, and the outcomes achieved. However, respondents also noted the scope of improving guidance, the timing of meeting planning, discussion, and team expertise composition.
Based on the feedback, EMA made recommendations specific to each type of meeting. For example, the agency advised the ITF team to evaluate the need for published information, guidance, and template updates. The recommendation followed feedback about the potential to improve the application form, IRIS platform, step-by-step guidance, and published information.
Some respondents criticized aspects of the Portfolio and Technology Meeting (PTM) process, telling EMA that the application form is inflexible and that they would like the list of questions in advance to better prepare for the meeting. EMA asked the PTM team to evaluate the application form and how to “enhance company preparedness before the meeting.”
EMA Report
European Pharmacopoeia Commission adopts chapter on using NGS to detect viruses
The European Pharmacopoeia Commission (EPC) has adopted a new general chapter on using next-generation sequencing (NGS) to detect viral contaminants.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) said NGS, also known as high-throughput sequencing, is increasingly used to test for viral extraneous agents in biological products. The technology can detect a broader range of known and unknown viruses than conventional tests, EDQM said, and can improve animal welfare by replacing in vivo tests.
EDQM said the chapter describes sequencing methodologies for detecting viruses in products including vaccines, recombinant proteins, viral vectors, and cell-based preparations. The chapter outlines the steps in the sequencing workflow, controls used in the routine test, and other parts of the process.
The chapter, one of EPC’s top priorities for 2023 to 2025, will enter into force in April 2026.
Press Release
Swissmedic seeks feedback on ICH solid oral dosage form bioequivalence guidance
The Swiss Agency for Therapeutic Products (Swissmedic) has published a draft International Council for Harmonisation (ICH) guidance document for consultation.
The document, ICH M13B, covers bioequivalence for immediate-release solid oral dosage forms. ICH has created the guidance as part of a planned series of documents to resolve issues about topics such as data analysis, biowaivers for additional strengths, and advanced study design considerations.
“Current regional or multi-regional guidelines have different views and criteria regarding design of bioequivalence studies and data analysis,” Swissmedic said. “This lack of harmonization can result in product developers having to follow different approaches in different regions and conducting additional BE studies, hampering streamlined global drug development.”
Swissmedic is accepting feedback until 9 July, the deadline for agencies across Europe. The deadlines in other parts of the world range from 13 June to 31 July.
Swissmedic Notice
EU starts first joint clinical assessments for medicinal products under HTA regulations
European authorities have started the first two joint clinical assessments for medicinal products under the Health Technology Assessment Regulation (HTAR).
Ireland’s National Centre for Pharmacoeconomics and Germany’s Institute for Quality and Efficiency in Health Care are looking at a treatment for low-grade glioma in children. For the other assessment, France’s National Authority for Health and Poland’s Agency for Health Technology Assessment and Tariff System are reviewing an advanced therapy medicinal product for the treatment of melanoma.
Under HTAR, the organizations carry out two joint clinical assessments in parallel with EMA’s reviews of the applications for authorization of the therapies. The work will generate reports that must be endorsed by the Member State Coordination Group on Health Technology Assessment within 30 days of a Commission decision granting a marketing authorization for the medicinal product.
Press Release
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