This guide is intended to provide guidance to applicants on Good Review Practices. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. It is not intended...
Please note that the South African Health Products Regulatory has hereby extended the deadline date for comments on the Borderline Products guideline (SAHPGL-CRO-01) from the 5th of September 2022, to the 8th of November 2022....
Business-As-Usual (BAU) is in the process of verifying submitted/received new medicine and variation applications. Industry is kindly requested to verify/confirm if all the applications that have been submitted to SAHPRA via BAU are being processed....
In keeping with SAHPRA’s strategic objectives – Digital Transformation has been a key focus are for SAHPRA ICT....
The Minister Of Health, In Consultation With The Minister Of Finance And SAHPRA, In Terms Of Section 35 (1) (Xxi) And (Xxxii) Read Together With Section 35(4) Of The Medicines And Related Substances, Made Regulations In The Schedule....
Exclusion Of Medicines, Medical Devices And In Vitro Diagnostics 22 May 2020 (IVD's) Donated To The State From The Operation Of Certain Provisions Of The Medicines And Related Substances Act, 1965 (Act No. 101 Of 1965)...
The Minister of Health, in consultation with the Authority, has in terms of section 35 of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), made the Regulations in the Schedule....
The Minister of Health has in terms of section 22A(2) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), on the recommendation of the South African Health Products Regulatory Authority (SAHPRA) made and updated the Schedules....
Exclusion Of Certain Alcohol-basedhand - Rubs From The Operation Of Specified Provisions Of Themedicines And Related Substances Act, 1965 (Act N(). 101 Of 1965)...