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