Regulatory Blog

South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH

ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products

EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure

MHRA Guidance: Registration & Regulating Medical Devices in UK

Health Canada: Guidance on Nitrosamine Impurities in Medications

USFDA Guidance: Animal Rule Developing Drugs for Prevention & Treatment "Acute Radiation Syndrome"

EMA Guidance: IRIS guide to Registration and Research Product Identifiers

Malaysia NPRA: Guideline on Electronic Labelling (E-LABELLING) for Pharmaceutical Products

Swiss Medic: Information sheet on Clinical Investigations with Medical Devices

Ireland's HPRA: Guide to SAR /Event Reporting for Human Organs Intended for Transplantation

IMDRF Guidance: CyberSecurity, Post-Market Surveillance, Personalized Medical Devices

USFDA Guidance: Transdermal and Topical Delivery Systems for ANDAs

USFDA Guidance: Format and Content for OTC Monograph Order Requests

USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations

UK MHRA: Guidance on Good Clinical Practice for Clinical Trials

USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision

USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API

UK MHRA: MHRA Fees 2023 & Guidance on How to Draft a Direct Health Care Professional Communication

Japan's PMDA: Reporting ADR & Defects during Clinical Trials using e-Application Data System