Regulatory Blog

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