Quality Management Systems
Safety, Efficacy, Support
News
Finalisation of SAHPRA’s new registrations backlog database following submission of Application Surveys
16 May 2019SAHPRA is publishing the list of new registration applications that will be evaluated as part of the Backlog Clearance Program.
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SAHPRA requests industry comments on POST- MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA GUIDELINE
14 May 2019Open Amended Post-Marketing Reporting of Adverse Drug Reactions to Human Medicines in South Africa Guideline
Comments to be sent to adr@sahpra.org.za
Comment Period 14 May 2019 - 13 June 2019
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SAHPRA requests industry comments on the on the draft Variations Addendum for Orthodox Medicines, eCTD and eSubmission Guidelines, and New Registration Validation Template.
11 May 2019Comment Period 10 May 2019 - 24 May 2019
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WHO or WHAT is SAHPRA
10 May 2019SAHPRA is the South African Health Products Regulatory Authority formaly known as the Medicines Control Councel (MCC).
Click here to find out more about SAHPRA as the new regularor.
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Welcome
The Medicines Control Council applies standards laid down by the Medicines and Related Substances Act, which governs the manufacture, distribution, sale, and marketing of medicines.
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Publications
Acts, regulations, notices, registrations, application forms, guidelines, safety alerts and workshops are available for download when selecting the publications section.
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safety information
Access the latest medicines safety information, updates and press releases
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