Policy and regulatory updates from 75 official public sources across the EU, UK, Switzerland and the US. Updated several times a week.
The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls). The special controls that apply to the device type are identified in thi...
US Federal Register - FDA RulesNewThe Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other thin...
US Federal Register - FDA Guidance NoticesNewList of Field Safety Notices from 20 to 24 July 2026.
UK MHRAUpdate: Chikungunya-Frankreich Neu Sicherheitsinformation | Blut & Gewebe | 27.07.2026 Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der französischen Behörde mitgeteilt...
Austria BASGThe Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This guidance is one...
US Federal Register - FDA Guidance NoticesStátní ústav pro kontrolu léčiv v souladu s ustanovením § 39n odst. 1 zákona č. 48/1997 Sb. o veřejném zdravotním pojištění a o změně a doplnění některých souvisejících zákonů (dále jen „zákon“) zveřejňuje Seznam cen ...
Czechia SUKLΑναρτάται στην ιστοσελίδα του ΕΟΦ, σήμερα Δευτέρα 27.7.2026, προς διαβούλευση, αρχείο με την πρόταση του Τμήματος Τιμολόγησης του ΕΟΦ ως
Greece EOFThe Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction into class II (special controls). The special controls that apply to the device type a...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators into class II (special controls). The special controls that apply to the device type are identified in th...
US Federal Register - FDA Rules27.07.2026. Lai samazinātu administratīvo slogu un atvieglotu informācijas iesniegšanu, Zāļu valsts aģentūra ir izstrādājusi jaunu tiešsaistes formu, kas paredzēta aptieku un zāļu lieltirgotavu darba laika izmaiņu paz...
Latvia ZVA (State Agency of Medicines)Az NNGYK indikáción túli gyógyszerrendelési ajánlásai link: Gadoteric acid, gadobutrol, gadoteridol, gadopiclenol hatóanyagú gyógyszerek alkalmazása dinamikus kontrasztos MR limphographia-ban fiatal f
Hungary NNGYKUpdate: Dengue - Frankreich und Überseegebiete Neu Sicherheitsinformation | Blut & Gewebe | 23.07.2026 Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der französischen Behörde m...
Austria BASGUpCard 3 mg Tabletten für Hunde Neu Rückruf | Tierarzneimittel | 23.07.2026 Rückruf aufgrund falscher Wirkstoffangabe in der Gebrauchsinformation
Austria BASGLIBTAYO 350 mg Konzentrat zur Herstellung einer Infusionslösung Neu Rückruf | Humanarzneimittel | 24.07.2026 Rückruf aufgrund fehlerhafter Verbördelung
Austria BASGSicherheitsinformation betreffend Produktfälschung: Hearing aid Neu Sicherheitsinformation | Medizinprodukte | 24.07.2026 Das Bundesamt für Sicherheit im Gesundheitswesen (BASG) warnt vor e...
Austria BASGStátní ústav pro kontrolu léčiv v souladu s ustanovením § 39zb odst. 1 zákona č. 48/1997 Sb. o veřejném zdravotním pojištění a o změně a doplnění některých souvisejících zákonů (dále jen „zákon“) zveřejňuje Seznam cen...
Czechia SUKLThe Food and Drug Administration (FDA) is classifying the over-the-counter test to detect SARS-CoV-2 from clinical specimens into class II (special controls). The special controls that apply to the device type are ide...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the intraoperative surgical angle measurement tool into class II (special controls). The special controls that apply to the device type are identified in this orde...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the prognostic test for assessment of chronic kidney disease progression into class II (special controls). The special controls that apply to the device type are i...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the diabetes digital behavioral therapeutic device into class II (special controls). The special controls that apply to the device type are identified in this orde...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Evonik Corporation, proposing that we amend our food additive regulations to provide for the safe us...
US Federal Register - FDA RulesInformuojame, kad laikinai sutriko šių vaistinių preparatų tiekimas Lietuvos Respublikos rinkai. NPAKID7 Vaistinio preparato pavadinimas Veiklioji medžiaga Stiprumas Farmacinė forma Kiekis pakuotėje Registruoto...
Lithuania VVKTFecha de publicación: 23 de julio de 2026 NIPO: 134-24-008-4 Legislación Implementación de reglamentos de productos sanitarios REGLAMENTO DE EJECUCIÓN (UE) 2026/977 DE LA COMISIÓN de 4 de mayo de 2026 por el que se es...
AEMPS (Spanish Medicine Agency)Upozornění držitele rozhodnutí o registraci léčivého přípravku Paricalcitol Fresenius, 5mcg/ml inj. sol. 5x1ml.
Czechia SUKL