Modification of the Drug Master File (DMF) Form
1 May 2023 – the Swissmedic published the modified DMF form.
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Changes to the Forms for New Authorizations of and Variations to Human and Veterinary Medicinal Products
1 May 2023 – the Swissmedic published information on study design and data sources of RWE in application forms.
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Medical Devices Swissmedic Hospital Inspections 2021/2022 Annual Report
12 May 2023 – the Swissmedic published the 2021/2022 annual report of the Swissmedic Hospital Inspections on Medical Devices.
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Changes to the Guidance Document GMP Compliance by Foreign Manufacturers and the Form Declaration by the Responsible Person for Foreign Manufacturers
1 May 2023 – the Swissmedic published updated guidance documents on clarification of the requirements for the submission of audit reports.
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ICH E6(R3) Good Clinical Practice Guidance – Step 2 Public Consultation
2 May 2023 – the UK MHRA Inspectorate announced Step 2 – Public Consultation – of the ICH GCP guidance.
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