News

SAHPRA briefs the National Press Club on the Backlog Clearance Project

22 Aug 2019
SAHPRA briefed members of the National Press Club at Court Classique Boutique Hotel in Pretoria on 22 August 2019 at 11h0.
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Section 21 Medicines applications for human use

08 Aug 2019
Section 21 Applications for Human Use- Frequently Asked Questions (FAQs)
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API names updated to align with WHO INN

02 Aug 2019

Update - 
SAHPRA has updated and amended the approved South African API names to bring them in line with WHO INN.

The amendment process allows for a five-year transition period to allow industry to bring medicine labelling in line with the policy commencing in June 2019 and ending in June 2024. 

 


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Submission of Business as Usual (BAU) registration and variation applications

01 Aug 2019
To Industry Partners

The aim of this communication is to guide industry regarding the submission of BAU registration and variation applications for human medicines (excluding Complementary Medicines).
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Launch of the Type II Variations Deep-Dive survey

01 Aug 2019
To All Industry Partners

As discussed in last week’s go-live workshop, SAHPRA is opening the Type II Variations Deep-Dive Survey today. The survey will facilitate work planning, and assist in the definition of the Type II resubmission windows of the Backlog Clearance Program.
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Publication of final versions of various guidelines

05 Jul 2019
SAHPRA is pleased to announce the publication of multiple guidelines (including Tranche 1 and Tranche 2 documents). Thank you to industry for your comments, which were duly considered. Please note that the implementation date of the Professional Information (PI) and Patient Information Leaflet (PIL) Guidelines is contingent on regulation amendments currently out for comment. The implementation date of the Variations Addendum is contingent on the go-live of the Digital Variations Portal. Development of the portal is underway, and additional communication will follow. Timelines for submitting in eCTD and eSubmission format will be detailed in the Roadmap (2.26), an updated version of which will be published shortly.
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Publication of the Professional Information and Product Information Leaflet

01 Jul 2019


SAHPRA publishes the first version of the PI and PIL repository.

SAHPRA has published the first version of the PI and PIL repository, containing 11 products associated with the first resubmission window of the Backlog Clearance Program. In the interest of sharing the latest SAHPRA-approved information as soon as possible, these PI and PILs are still in their current, MCC format. All published PI and PILs will be updated when relevant variation applications are finalised (e.g., imminent format updates in accordance with the latest SAHPRA PI and PIL guidelines).  


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Exemption of certain products containing Cannabidiol from certain provision of the Act for a period of 12 months

28 May 2019

The Miniter of Health in recognition of the known safety profiles of the low-dose Cannabidiol (CBD) has decided to exclude certain CBD containing products from Schedule 4 for a period of 12 Months as stipulated in the govermament Notice No. R756, Goverment Gazette No. 42477.

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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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