Regulatory Blog

UK MHRA: Guidance on Register Medical Devices to Place on the Market

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

Australia TGA: Clinical Evidence Guidelines

Swiss Medic: Biosimilar Authorisation Guidance

South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments

USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model

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

USFDA MD Guidance: Enforcement Policy for Clinical Electronic Thermometers

USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption

TGA Guidance: General Dossier Requirements

UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device

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