GENERAL, ECTD & HUMAN MEDICINES GUIDELINES

Document NumberFile NameYearVersionDocument TypeDownload
Industry Communication on Interim Measures Pending Update of Variation Addendum 20201Guideline
2.01General information guideline201910Guideline
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 Procedure20212Guideline
2.64Availability of medicines for use in a public health emergency20211Guideline
2.66Guideline for Lot release of human vaccines20211Guideline
4.01 SA Guide to Good Manufacturing Practice20199Guideline
5.08Reliance Guideline20212Guideline
9.125BAU variations communication20218Guideline
9.127eCTD IMPLEMENTATION ROADMAP COMMUNICATION20211Guideline
9.128PILOT: BAU NEW MEDICINE APPLICATIONS FOR REGISTRATION20212Guideline
9.129Re-submission of BAU New Medicines Applications from 2018 and 201920211Guideline