Swissmedic Guidance on Product Information for Human Medicinal Products
USFDA Guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics
UK MHRA Guidance: How Marketing Authorisation Applications referred under Article 29 are Handled
South Africa's SAHPRA: Communication to Industry on Quality Variations
South Africa-SAHPRA: Engagement Portal
Swissmedic Guidance: Combined Studies: Clinical Investigations of Medical Devices, Medicinal Products, and Advanced Therapy Medicinal Products (ATMPs)
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
SwissMedic Med Dev: Clinical Investigations of Medical Devices & Performance Studies of In Vitro Diagnostics (IVD)
Australia's TGA Good Clinical Practice (GCP) Inspection Program
USFDA Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025
SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1
Swissmedic Guidance: Fast-Track Authorisation Procedure and Temporary Authorisation for Human Medicinal Products
MDCG Guidance: MDR requirements for Legacy Devices
US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
UK MHRA Guidance: Orphan Medicinal Products, Reference Medicinal Products (RMPs), and Handling of Active Substance Master Files (ASMFs) and Certificates of Suitability (CEP)
UK MHRA Guidance: Conditional Marketing Authorisations, Exceptional Circumstances Marketing Authorisations, and National Scientific Advice
USFDA Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials & Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
USFDA Guidance: Review of Drug Master Files in Advance of Certain ANDA Submissions
MDCG Med Dev: Guidance and Templates for Conformity Assessment Bodies, Notified Bodies, Designating Authorities, and Joint Assessment Teams