News
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European Medicines Agency: Global regulators call for advancing alternatives to animal testing
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Swissmedic: Revision of the Guidance document Authorisation Biosimilar
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Swissmedic: Adaptations required for issuing establishment licences and GMP certificates for manufacturers of active substances
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Swissmedic: Changes to the Guidance document “Import of a human medicinal product according to art. 14 para. 2 and 3 TPA (parallel import)”
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European Medicines Agency: Highlights of the September 2026 Management Board meeting
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Swissmedic: Swissmedic Portal Release – New Features Available from 23 September 2026
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Swissmedic: Advance notice regarding the Swissmedic Portal release of 23 September 2026
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European Medicines Agency: EMA concludes review of ipidacrine-containing medicines
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FOPH: Strengthening the supply of essential medicines
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Swissmedic: New guideline «Schweizerische Gute Praxis der Materiovigilance in der In-vitro-Diagnostik» (GPMV-IVD)
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Decision 6B_106/2026 of 9 September 2026
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Swissmedic: Swissmedic Journal 08/2026
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Swissmedic: ElViS 2.0 – Updated reporting tool for adverse drug reactions in E2B(R3) format
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Decision B-1906/2026 of 4 September 2026
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European Medicines Agency: PRAC starts safety review of injectable iron-containing medicines
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BGE 152 V 149
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Judgment of the General Court of the European Union in Case T 12/24 of 2 September 2026
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FOPH: Federal Council seeks to sustainably improve healthcare for people with rare diseases
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FOPH: Safety features on medicine packaging to remain voluntary
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Decision 9C_170/2026 of 2 September 2026
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Swissmedic: Simplification of applications for a change of status between main authorisation and export licence for veterinary medicinal products