Regulatory

The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including three orphans. A decision is also due on a previously-rejected Alzheimer’s drug that was under re-examination.

Two lawyers within EU legal chamber Axon Lawyers created a Green Team to cope with the rise in EU Green Deal and related environmental sustainability and compliance needs for medtechs. One of them, Jilles van der Hoek, explains why manufacturers should be getting a jump on future requirements.

AI-enabled tools deliver faster radiology reads, clinical decision-support, personalized treatment insights and continuous patient monitoring, but a new report from Firefinch Software and IMed Consultancy advises device developers how to enter and stay in this rapidly growing market.

Agency offered to drop annual IND fees for sponsors not conducting Phase I trials in US, but industry still raised several concerns about fee incentives for onshoring clinical development.

The first multinational clinical trial approval under the EU’s 70‑day fast-track pilot pathway is expected by the end of April 2026.

Smaller biotech companies without the regulatory resources of big pharma should approach the UK medicines regulator and health technology appraisal body for early, informal discussions on how to generate the right evidence.

Digitalization is expected to reform the European pharmaceutical industry. But it will also change perceptions towards technology and current regulatory skillsets.

Certain short-term EU market improvement measures are expected to be in place this month, said the European Commission, which has challenged device industry stakeholders for input and advice as the EU’s late-2025 bundle of device regulatory improvements begins to take shape.

EU data protection bodies back clinical trial harmonization under the draft Biotech Act, but insist on strong safeguards for sensitive health data.

Strengthening the European Medicines Agency’s capacity to analyze clinical and non‑clinical raw data, expanding real-world evidence infrastructure, and boosting AI literacy across the EU regulatory network all feature prominently in a new 2026–2028 workplan.

IMDRF’s playbook on regulatory reliance was in the spotlight at the Forum’s 29th meeting this week, on the heels of its new midterm regulatory strategy document. 2026 IMDRF chair Singapore used the occasion to announce unprecedented WHO acclaim for the nation’s device regulatory oversight.

The US FDA released one of the highest numbers of product-specific guidances for generic development in a single batch.