Clinical trials

BW101_10_004e_AA Guideline Clinical Trial Application Dossier (PDF, 545 kB, 24.04.2024)Valid until 31.10.2024

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

FO submission form (PDF, 5 MB, 17.11.2023)Valid until 31.10.2024

FO submission form (PDF, 5 MB, 01.11.2024)

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_018d_FO Klinische Studien der Kategorie B mit Arzneimitteln, die ionisierende Strahlen aussenden können (DOCX, 95 kB, 20.12.2018)

BW101_10_003e_AA Guideline Amendments Clinical Trials (PDF, 535 kB, 25.04.2024)Valid until 31.10.2024

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

BW101_20_002e_MB Safety of Medicines (PDF, 194 kB, 13.09.2022)Valid until 31.10.2024

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

FO submission form (PDF, 5 MB, 17.11.2023)Valid until 31.10.2024

FO submission form (PDF, 5 MB, 01.11.2024)

BW315_00_980e_MB Information Sheet Requirements for documents to be submitted for a clinical trial with TpP/GT/GMOs (PDF, 2 MB, 28.04.2023)

BW315_00_972e_WL Guidance document Gene Therapy/GMO Environmental Data (PDF, 2 MB, 28.04.2023)

BW315_00_971e_CL Checklist for TpP/GT/GMO clinical trials (PDF, 264 kB, 28.04.2023)

BW315_00_960e_FO Form Adverse Reaction Report CT ATMP (DOCX, 378 kB, 15.02.2024)

BW315_00_961e_MB Information sheet Mandatory reporting of adverse reactions during a clinical trial with ATMPs, other products (bacteriophages, etc.) and procedures (PDF, 368 kB, 15.02.2024)

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 781 kB, 01.09.2024)

BW600_00_016e_MB Performance studies with IVD (PDF, 728 kB, 01.09.2024)

BW610_10_021e_FO Authorisation clinical investigation MD (PDF, 1 MB, 01.11.2023)

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 01.09.2022)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 01.10.2023)

BW610_10_024e_FO Authorisation performance study IVD (PDF, 1 MB, 01.11.2023)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 01.10.2023)

BW610_20_021e_FO Amendments, notifications, reports MD IVD (PDF, 1 MB, 01.11.2023)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 01.09.2022)

BW610_20_023e_FO SAE-CH and DD-CH MD (PDF, 1 MB, 01.09.2022)

BW610_20_024e_FO SAE-CH and DD-CH IVD (PDF, 1 MB, 30.09.2022)