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Khabre desk
Recent reporting, analysis and explainers from the Regulation desk.
health
EMA’s human medicines committee recommended six new medicines and five extensions of existing medicines’ indications at its 12–15 October 2026 meeting. The recommendations are not final EU marketing authorisations.
health
At EMA’s first multi-stakeholder workshop on women’s health, Executive Director Emer Cooke called for a practical, measurable roadmap to address gaps in research, diagnosis and treatment. The agency plans to publish a report of the workshop’s findings and proposed next steps.
health
The European Medicines Agency has endorsed an ICMRA statement calling for scientifically valid alternatives to animal testing throughout the human-medicine lifecycle. Regulators also call for tighter justification of animal-based batch-release tests.
health
The European Medicines Agency plans to publish a roadmap by the end of 2026 to improve how women’s health is considered in medicines development and regulation. Ten proposed priorities include better clinical-trial representation, stronger evidence and clearer communication of benefits and risks.
health
EMA’s Committee for Medicinal Products for Human Use issued positive opinions for 12 medicines at its 14–17 September 2026 meeting, including a rabies vaccine, two biosimilars and two generics. The recommendations remain subject to European Commission decisions.