GENERAL, ECTD & HUMAN MEDICINES GUIDELNES

Document NumberFile NameYearVersionDocument TypeDownload
Industry Communication on Interim Measures Pending Update of Variation Addendum 20201Guideline
2.01General information guideline20196Guideline
2.02Quality and Bioequivalence20192Guideline
2.08aInterim Variations Addendum for Human and Veterinary Medicine20201Guideline
2.09Clinical guideline20192Guideline
2.14Guideline for Patient Information Leaflet for Human Medicines20192Guideline
2.16Guideline for Professional Information for Human Medicines20192Guideline
2.58Submission in eSubmission format20191Guideline
2.59Guideline for the APIMF Procedure20191Guideline
4.01 SA Guide to Good Manufacturing Practice20199Guideline