News

Finalisation of SAHPRA’s new registrations backlog database following submission of Application Surveys

16 May 2019
SAHPRA 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 2019

Open  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 2019

Comment Period 10 May 2019 - 24 May 2019
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WHO or WHAT is SAHPRA

10 May 2019
SAHPRA 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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