Action for SACRA for 2018

Regulatory Guide:

• Continue to keep members updated on various regulatory developments (MCC to SAHPRA) during the course of the year, including assisting with triaging items received from MCC, ITG and other stakeholders (ensuring we bring you the most recent and relevant information)

• Develop additional Q&As, initially it will be for the new CTF1 form, to allow the industry to share knowledge gained thus far (including informal MRA responses to questions and CTC responses.

Dispensing license:

• Guidance document to compare requirements for dispensing from a typical Pharmacy (drawing on the presentation Nicola presented during our last SACRA meeting) and requirements for a dispensing license, in terms of what is expected with reference to a clinical trial

• Be in contact and assist SAHPRA with their planned guidance document re Dispensing license in order to make it as comprehensive as possible in order to address needs of Industry and Investigator sites

• Gap analysis to be conducted once guidance document has been finalized and realized as to what are still missing and what might require legislative intervention.

EC’s at private hospitals:

• Provide support to CRO sector (Annie Gough) - helping with challenges around EC approval to be provided by private 

• Support sites develop ICF and IMP management procedures (to help prevent ICF & IMP related audit / inspection findings).