SwissMedic Guidance on Fast-Track Authorisation, Temporary Authorisation and Variations & Extensions
USFDA Guidance: Drug-Drug Interaction Assessment & Nonclinical Evaluation of Immunotoxicity
Philippine FDA: Guidelines for Importation and Exportation of Finished Drug Products & Raw Materials
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
USFDA Guidance: GASK in Drug & Biologics: Nonclinical Info & Slide Imaging in Nonclinical Toxicology
USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations
EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages
USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products
UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF
South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
Ireland's HPRA: Guidance on Reporting & Investigation of Quality Defects
Swiss Medic: Guidance on Transfer of Marketing Authorisation
EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS
USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure
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