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...

During the 20 November 2017 Clinical Trials Stakeholder Workshop, Dr Diale presented a number of revisions to existing clinical trial forms to the attendees. These included the application to conduct a clinical trial form (CTF1), the 6-monthly progress report form and...

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...

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