Adverse Drug Reactions and Quality Problem Reporting Form - for both public and private sector and includes herbal products....
This information manual ("the Manual") is published in terms of Section 14 of the Promotion of Access to Information Act No. 2 of 2000 ("the Act)
Download PAIA manual here...
The application form shall be used for an application for lot release of a human vaccine submitted to the South African Health Products Regulatory Authority....
This is a form to report ADRs in clinical trials....
This form is to be completed six-monthly from the date of approval of the clinical trial by the South African Health Products Regulatory Authority (SAHPRA). ...
This is the primary application form for applicants to use in case of an application for additional investigators or change of investigator(s)/sites and application for additional sites....
This is the primary application form for applicants to use for the purpose of amending an already approved study protocol....
Due to the rapidly changing dynamics of the condition/disease, it has become necessary for the South African Health Products Regulatory Authority (SAHPRA) to introduce a two-weekly public health emergency (PHE) Abridged Interim Safety and Futility Monitoring Report Form for clinical trials. ...
Application to conduct a clinical trial with limited information....