Urgent request for information on Clinical Trials

Dear Colleagues

I wish to kindly request that you provide us the following information urgently, starting immediately, only for Clinical Trials.

  1. Names of Clinical Trials that have been approved by SAPHRA and will be taking place in the next 5 years.

  2. Protocol Numbers of each Clinical Trial.

  3. The site where the trial will be taking place.

  4. MTA for each trial.

  5. The contact person to facilitate and oversee the below.

  6. Telephone/Cellphone number and E-mail address.

  7. The company address

This will assist in a proposal to the DG to provide a blanket permit for each company for a year to reduce the burden of each investigator applying for a permit almost everyday.

The blanket permit will be renewed annually.

Email directly to: importexportpermit@health.gov.za

The intention is also for the companies to take the responsibility and furnishing the National Department of Health in reporting on a 6 monthly basis on all the shipments made in terms of each import and export by name, date, etc. as per requirement of R.181:

Regulations relating to import and export of Human Tissue, Blood, Blood Products, Cultured Cells, Stem Cells, Embryos, Foetal Tissue, Zygotes and Gametes.

It is my hope that this process will fastrack the obstacles in terms of delays.

This will be implemented as a temporary measure until the system where applicants can capture and upload is finalised.

Sincerely,

Ms Pakiso Netshidzivhani.

Chief director for Violence, Emergency Medical Services and Forensic Pathology services

Department of Health,

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