November has been a productive month of meetings, workshops and robust industry debates. A number of key issues were discussed during these November meetings:
The Industry Task Group - 3 November
MCC Industry Workshop - 4 November
Import/Export License Meeting - 8th November.
MCC INDUSTRY WORKSHOP
In partnership with the Medicines Control Council (MCC), the Department of Health (DoH) an SACRA, a number of industry issues were discussed and debated at the MCC Industry Workshop held in Johannesburg on the 4 November 2016. Amongst the issues discussed South African Health Products Regulatory Authority (SAHPRA) and IRS along with Post-trial access, Monitoring and oversight of clinical trials, CRA and CRSM scientific training and the completion of CTF1 documentation.
A number of protocol amendments were presented and discussed at length. MCC has confirmed that the guidelines for the Importation and Exportation of Clinical Trial Material is available on their website (http://www.mccza.com/Publications).
With regards to sites and clinical trials, discussions include clarity on Study Insurance, Site Personnel (co-PI, Backup), Participant & Caregiver Renumeration, Background Care & Rescue Medication, GCP Training & Consent Forms and dedicated email address is provided for SAE reporting.
Presentations on the MCC workshop will be made available on the MCC Industry News.
INDUSTRY TASK GROUP
Request was made to form MCC-Industry policy task team to assist with ensuring compliance with regards to submission documentation and processes.
DoH Biological Samples Import Export Department
No laboratories will be granted permits. The act does not give allowance for laboratories to be permit applicants.
Please refer to the FAQ for clarification before contacting the department.
All SACRA members will be able to access the specific feedback from our November meetings via the SACRA website. Please visit the SACRA website, RESOURCES | MCC | 2016 Downloads - click to download the feedback.