We provide project-based mentoring for regulatory departments and bespoke training for your regulatory affairs team. New CPD requirements have been published by the South Africa Pharmacy Council and as of January 2020 there is a set expectation for compliance thereto. The GxP requirements in terms of the Medicines Act place emphasis on training and on-going development […]
eCTD has been mandated as the only means of submitting new applications for registration for pharmaceutical and biological Health Products. Significant changes have been implemented for the administrative particulars for the ZA eCTD. The introduction of several new template documents and guidelines requires considerably more regulatory work to go into the creation of registration applications
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The Medicines and Related Substances Act was amended on the 22nd of May 2017 by the promulgation of the Act 72 of 2008 and Act 14 of 2015 – the Medicines and Related Substances Amendment Acts. The General Regulations to the Medicines Act were amended on the 25th of August 2017, with significant changes to the
Changes to Legislation: Medicines and Related Substances Act Read More »
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