UK MHRA: Guidance on Submitting Changes to Labelling and Patient Information Leaflets
Singapore's HSA: Post-Industry Consultation Updates on eCTD Implementation in Singapore
UK MHRA Guidance: Apply for a Parallel Import Licence
Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
USFDA Guidance Q&A: Translation of Good Laboratory Practice Study Reports
UK MHRA: Guidance on Change of Ownership: Marketing Authorisation Process
Switzerland's SwissMedic: Guidance on Formal Requirements
USFDA Guidance: Real-Time Oncology Review (RTOR)
MHRA Guidance: Common Issues Identified during Clinical Trial Applications
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
TGA Guidance: General Dossier Requirements
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK
USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment
USFDA Guidance: Quality Considerations for Topical Ophthalmic Drug Products & Stimulant Use Disorder
EMA Guidance: Post-Authorisation Procedural Advice for Users of the Centralised Procedure
UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK
EMA Guidance: Qualification of Novel Methodologies for Drug Development, Guidance to Applicants