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SwissMedic - Technical Requirements for the Submission of Clinical Trial Application

On 4-May-2022 the Swissmedic shared information on the technical requirements for submitting applications for clinical trials for...

SFDA - Guidelines for Variation Requirements

On 10-May-2022 the Saudi Food & Drug Authority (SFDA) released updated guidance on "Guidelines for Variation Requirements". These...

USFDA Guidance on Product Quality Assessments - Benefit-Risk Considerations

Earlier on 9-May-2022, FDA announced that a draft guidance document was available to assist the industry regarding the Benefit-Risk...

SAHPRA Guidance on Pharmacovigilance Inspections for Human Medicinal Product

South African Health Products Regulatory Authority updated its guidance on Pharmacovigilance Inspections for Human Medicinal Products....