GENERAL, ECTD & HUMAN MEDICINES TEMPLATES

Document NumberFile NameYearVersionCategoryPDF TemplateWord Template
SAHPRA Variation Validation Template for eCTD20201Template
SAHPRA Variation Validation Template for eSubmission20201Template
6.16New Registration Validation Template for eCTD20203Template
6.30New Registration Validation Template for eSubmission20191Template
6.31Summary of Critical Regulatory Elements (SCoRE)20213Template
6.32Bioequivalence Trial Information Form (BTIF)20213Template
6.33Abridged review template20191Template
6.34Verified review template20191Template
6.38Additional Strength Biowaiver Application Form20213Template
6.39Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form20213Template