February 21, 2018

Dear All,

Following the release of the new MCC (SAHPRA) 6 -monthly progress report template, there have been a number of concerns and queries raised by industry regarding the completion of the form.

SACRA has been advised that revisions and clarifications are being made...

On 01 June 2017, the President of South Africa proclaimed revisions to the Medicines Act. These revisions provide for the creation of a new regulatory authority, known as the South African Health Products Regulatory Authority (SAHPRA). This new regulator will be respon...

Action for SACRA for 2015

  1. SACRA to have a reference document on website on TransCelerate.

  2. Work on a response to the MCC inspectorate about safety detection, with a focus on 100% source review at minimum and SDV as per monitoring plan.

  3. CRA Training:

    • ...
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