Switzerland's SwissMedic: Guidance on Authorisation Biosimilar
Health Canada Guidance: Preparation of Regulatory Activities in Non-eCTD Format
MHRA Guidance: 150-Day Assessment for National Applications & Parallel Import Licence
Philippines FDA: Guidelines on the Application for License to Operate
USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
South Africa's (SAPHRA): Guideline on Pharmacovigilance Systems
SwissMedic Guidance: Orphan Drug, New Active Substance & Prior Notification
SwissMedic Guidance on Fast-Track Authorisation, Temporary Authorisation and Variations & Extensions
USFDA Guidance: Drug-Drug Interaction Assessment & Nonclinical Evaluation of Immunotoxicity
USFDA Guidance: Medical Device Submissions "The Q-Submission Program"
USFDA Statement: New Patient Medication Information - Medication Guide for Patients
Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals
USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
USFDA Guidance: GASK in Drug & Biologics: Nonclinical Info & Slide Imaging in Nonclinical Toxicology
South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1
USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products
South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS
USFDA Guidance: Assessing User Fees Under the PDUFA of 2022