Sperimentazioni cliniche

BW101_10_004e_MB Guideline Clinical Trial Application Dossier (PDF, 531 kB, 01.11.2024)

FO submission form (PDF, 5 MB, 19.03.2025)

BW101_10_002e_MB Questions and answers on clinical trials with medicinal products (PDF, 526 kB, 01.11.2024)

BW101_10_006e_AA Guidance Pharmaceutical Quality Dossier (PDF, 296 kB, 01.04.2015)

BW101_10_018f_FO Essais cliniques de catégorie B faisant intervenir des Médicaments susceptibles d’émettre des rayonnements ionisants (DOCX, 95 kB, 20.12.2018)

BW101_10_003e_MB Guideline Amendments Clinical Trials (PDF, 417 kB, 01.11.2024)

BW101_20_002e_MB Safety Reporting in clinical trials (PDF, 313 kB, 01.11.2024)(finora: BW101_20_002e_MB Safety of Medicines)

FO submission form (PDF, 5 MB, 19.03.2025)

BW315_00_980i_MB Promemoria Requisiti della documentazione da fornire per le sperimentazioni cliniche con espianti standardizzati TG/OGM (PDF, 2 MB, 28.04.2023)

BW315_00_972i_WL Guida complementare terapia genica/dati sull’ambiente OGM (PDF, 2 MB, 28.04.2023)

BW315_00_971f_CL Liste de contrôle pour essais cliniques avec des TrSt/TG/OGM (PDF, 267 kB, 28.04.2023)

BW315_00_960i_FO Formulario Notifica eventi indesiderati Sclin ATMP (DOCX, 374 kB, 15.02.2024)

BW315_00_961i_MB Scheda informativa Obblighi di notifica per eventi indesiderati durante una sperimentazione clinica con ATMP e altri prodotti (batteriofagi ecc.) e procedimenti (PDF, 364 kB, 01.11.2024)

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 781 kB, 31.10.2024)

BW600_00_016e_MB Performance studies with IVD (PDF, 731 kB, 31.10.2024)

BW610_10_021e_FO Application clinical investigation MD (PDF, 1 MB, 29.11.2024)

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 29.11.2024)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 09.05.2025)

BW610_10_024e_FO Application performance study IVD (PDF, 1 MB, 29.11.2024)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 09.05.2025)

BW610_20_021e_FO Modifications, notifications, reports MD IVD (PDF, 1 MB, 20.01.2025)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 30.01.2025)

BW610_20_023e_FO SAE-CH and DD-CH MD (PDF, 1 MB, 29.11.2024)

BW610_20_024e_FO SAE-CH and DD-CH IVD (PDF, 1 MB, 29.11.2024)