GUIDELINES NOTICE BOARD

Document NumberGuideline NameDate UploadedVersionUnitDownload
9.128PILOT: BAU NEW MEDICINE APPLICATIONS FOR REGISTRATIONJuly 27, 20212HEALTH PRODUCTS AUTHORIZATION
9.128PILOT: BAU NEW MEDICINE APPLICATIONS FOR REGISTRATIONJuly 01, 20211HEALTH PRODUCTS AUTHORIZATION
9.127eCTD IMPLEMENTATION ROADMAP COMMUNICATIONJuly 01, 20211HEALTH PRODUCTS AUTHORIZATION
Guideline on the payment of fees to SAHPRA May 2021June 25, 20211FEES
SA GCP GuidelinesJune 15, 20213CLINICAL TRIALS
9.125BAU variations communicationMay 27, 20218GENERAL, ECTD & HUMAN MEDICINES GUIDELNES
9.126Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2May 27, 20211BIOLOGICAL MEDICINES EVALUATION AND RESEARCH UNIT (BMERU)
8.05CLASSIFICATION of MEDICAL DEVICES and IVDsMay 18, 20214MEDICAL DEVICES
5.08Revised Guideline -DONATION OF MEDICINES MEDICAL DEVICES AND IVDsMay 17, 20213MEDICAL DEVICES
2.63GUIDELINE FOR ADVERSE DRUG REACTIONS (ADRs) REPORTING FOR HEALTHCARE PROFESSIONALSMay 17, 20211PHARMACOVIGILANCE