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The European Commission has published two delegated acts that expand the list of well-established technologies (WET) under the Medical Devices Regulation (MDR) that are exempt from conducting clinical investigations and technical assessments. The first regulation applies to implantable devices and Class III devices, while the second regulation focuses on Class IIb implantable devices.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The European Medicines Agency (EMA) has published a concept paper to update its guidelines on developing antifungal drugs to treat and prevent invasive fungal disease (IFD). The guideline has been updated 17 times since the Committee for Medicinal Products for Human Use (CHMP) first adopted it in 2003, but regulators argue it should be updated again to reflect the latest scientific consensus and regulatory thinking.

European groups have raised questions about how patient preference studies (PPS) can be adapted from one region to another under the International Council on Harmonization (ICH) E22 guideline. Similar to their counterparts in the US, one major pharma group in the EU expressed the need for caregiver input for these studies. This feedback was in responses submitted by industry groups and manufacturers to the European Medicines Agency (EMA) during its call for comments on the guideline.

The European Parliament has called for the temporary suspension of plans to make drugmakers pay for wastewater treatment.

Among oncology drugs first approved by the US Food and Drug Administration, other regulatory authorities varied in how they approved the same products, both in terms of the regulatory frameworks and the evidentiary thresholds used as the basis for the approvals, according to recent research published in Frontiers in Pharmacology.

The European Commission has adopted new harmonized standards for medical devices and diagnostics but established a five-year transition period to give manufacturers time to adapt their processes.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.