Current News

UCT Institutional Data Repository launched

Did you know that UCT recently launched an Institutional Data Repository? It is called ZivaHub: Open Data UCT. The purpose of the repository is to house research data sets that are required 

EU adopts Medical Device Regulations

On 5 April, two new regulations on medical devices were adopted by the EU namely EU2017/745 and EU2017/746. These replace the existing Directives for Medical Devices and In-Vitro Medical Devices, respe

EMA Guideline on TMF - open for comment

The European Medicines Agency (EMA) have issued a guideline on GCP compliance in relation to the trial master file (TMF), and invites comments from stakeholders. The guideline was compiled by the Good Clinical Practice Inspectors Working Group and the

Revised ICH GCP Guideline Published

The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline (published in November 2016).

Finally: Medical Device Regulations

Justin Malherbe, at law firm Norton Rose Fulbright South Africa writes that the long-awaited ‘Regulations relating to Medical Devices and in vitro diagnostic medical devices (IVDs)’ were published by the Mi