South Africa : Vaccines
Relevant Regulatory Harmonization Initiatives
Southern African Development Community (SADC).
African Medicines Registration Harmonization Initiative (AMRH).
South Africa is also a member of the African Vaccine Regulatory Forum (AVAREF).
Clinical Trial Import Authorization
Unregistered investigational products may be brought into the country after MCC approves of the study protocol. To import samples before trial approval, the MCC must issue a permit.
General guidelines on importation and exportation of medicine are available here.
Clinical Trial Data Requirements
1. Covering letter.
2. Cover sheet.
4. Completed Application form.
5. All documents to be submitted in duplicate with two electronic copies.
6. Additional 25 copies of the application form itself must be submitted.
8. Patient Information Leaflet (PIL) and Informed Consent Form.
9. Standardized MCC contact details/wording to be added to PILs.
10. Investigators Brochure/Package insert.
11. Signed investigator(s) CV(s) in MCC CVs format.
12. Signed Declaration by Principal investigator(s).
13. Signed joint declaration by Sponsor/National Principal investigator.
14. Signed Provisional declaration by Co- or Sub-investigators.
15. Signed Declaration by regional monitor.
16. Indemnity and Insurance Certificate and/or Proof of Malpractice insurance for clinical investigators.
17. Ethics committee(s) approval or Copy of letter submitted to Ethics committee(s).
18. Diskettes to be submitted in word.
19. Financial declaration.
Clinical Trial Estimated Timeline
According to the Division of AIDS Clinical Reserch Support Services, there is a 12 week minimum review period, with no set maximum. Bioequivalence studies have a 7 day review period.
Clinical Trial Costs
Information currently not available.
In-Country Manufacturing Requirements
South Africa has adopted Good Manufacturing Practices, which are outlined here.
According to South African's Good Clinical Practice Guidelines, Second Edition, all participants must be covered by comprehensive insurance for injury and damage.
The sponsor should compensate participants that suffer injury or death attributable to a medical product or clinical intervention. If a child in-utero is injured, compensation should be paid to the partipant's mother.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
16 clinical trials approved from June 2012 to June 2014.
Product Registration Data Requirements
An application for registration includes:
-Labeling information (package insert, patient information leaflet, label).
-Foreign registration details (list of countries where applications have been submitted and their status, copy of registration if already granted by the US (FDA), EU (EMEA), UK (MHRA), Sweden (MPA), Canada (Health Canada), Australia (TGA), or Japan (MWH).
-Pharmaceutical and biological availability.
-Summary of core data in support of clinical safety and efficacy.
-Pharmaceutical Expert Report.
-Pre-Clinical Expert Report.
-Clinical Expert Report.
-Summary of active pharmaceutical ingredient characteristics.
-Description of production and ingredients used.
-Description of formulation.
-Stability data for finished pharmaceutical product.
Full product registration requirements are outlined here.
Product Registration Costs
Fees vary based on category of medicine. A full list of fees is available here.
Post Registration Labeling Requirements
Labelling requirements are found in Section 8 of the Medicines and Related Substances Act 101 of 1965, which can be found here.
January 14, 2016.
Post Registration Pharmacovigilance Requirements
Applicants are expected to have in place a system for pharmacovigilance system to manage safety data. The MCC recommends that the applicant have a full-time person in South Africa responsible for pre- and post-marketing surveillance. The applicant should have a Pharmacovigilance Officer (even if he or she is not in South Africa) to be responsible for pharmacovigilance activities. There should be full documentation of the activities and procedures of the Pharmacovigilance Officer.
The Pharmacovigilance Officer is responsible for:
-establishing and maintaining a system that ensures all information about suspected Adverse Drug Reactions (ADRs) is collected and collated.
-serving as a contact person or the MCC and National Adverse Drug Event Monitoring Centre (NADEMC), and fulfilling any requests from them.
-overseeing and preparing ADR reports, Periodic Safety Update Reports (PSURs) when necessary, company-sponsored post-registration study reports when necessary, and ongoing pharmacovigilance evaluation after registration.
Annually, a summary report should be submitted to the NADEMC which contains all ADR reports during a specific reporting period. The summary report should include:
-local usage of each formulation.
-critical analysis of the ADRs for each medicine. This includes identification of any new ADRs or risk factors , changes in reporting rates of ADRs, and any new safety issues related to drug interactions, overdose, drug abuse or misuse, and use in pregnancy or special patient groups.
-Any actions taken.
-Simple risk-benefit statement for ongoing use and monitoring of the medicine.
-Line listing of ADRs including source, patient gender and age, formulation (including strength), daily dose, treatment dates and duration or time to onset, adverse reactions, seriousness, outcome and comment.
-All serious, suspected ADRs must be reported within 15 days of receipt of information.
-All non-serious, suspected ADRs should be reported in the summary report.
-Foreign ADRs should be reported in the context of a specific safety issue or upon request by MCC and NADEMC.
-PSURs should only be submitted when requested by MCC and NADEMC, when submission is a condition of registration, as part of a desire to amend the original conditions of registration, when the product has already been marketed elsewhere and has been submitted in South Africa for registration, and when a clinical trial is being carried out with a product already registered in other countries.
-Authorities must be informed within 3 calender days of first knoweledge if new evidence is found tha can hve a significant impact on benefit/risk assessment of a medicine.