Regulatory Blog

Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format

Swiss Medic: Biosimilar Authorisation Guidance

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: Supplements for Approved Premarket Approval or Humanitarian Device Exemption

TGA Guidance: General Dossier Requirements

USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities

USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices

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

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

USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area

EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation

MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)