Swissmedic Guidance on Product Information for Human Medicinal Products
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
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
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
US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling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
EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products
Switzerland's Swiss Medic Guidance: Transfer of Marketing Authorisation
Australia TGA: eCTD AU Module 1 and Regional Information v3.2
USFDA Guidance : Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
UK MHRA Guidance: Pre-submission Advice & Support