The WHO and SAHPRA have agreed to pilot a new review mechanism for locally manufactured vaccines to speed up the process, and has called for expressions of interest.
The current WHO Pre-Qualification (WHO PQ) mechanism requires that a health product, in this case, a vaccine, first be authorised by the reference country's National Regulatory Authority (NRA) before submission by the manufacturer, and in efforts to support and boost local manufacturing, SAHPRA approved a policy in this regard, which was published in June 2025.
The lengthy and drawn-out process of getting NRA approval before WHO PQ was cited by several stakeholders as a barrier, which has led to WHO and SAHPRA agreeig to pilot a parallel review mechanism of locally manufactured vaccines, in which the local applicant does not have to wait for SAHPRA’s approval.
This would have benefits not only for the regulating body itself but the industry and the public.
These are:
1. SAHPRA could continuously improve its efficiency and regulatory process and mechanism;
2. Leverage on the capability SAHPRA has as an ML3 (vaccines) NRA;
3. Applicants will not have to wait for SAHPRA authorisation before submitting to WHO PQ;
4. Timeous access to the products by both South Africans and the African continent as these vaccines will be procured by other countries; and
5. WHO and SAHPRA will demonstrate commitment for supporting local manufacturer of vaccines on the African continent.
Key principles/conditions will be maintained:
1. WHO PQ will retain and maintain its objectivity and it is proposed that the outcome only be communicated to the applicant post the SAHPRA outcome;
2. SAHPRA’s review and assessment of the product will remain independent of WHO PQ’s assessment. Similarly, WHO will retain its independent assessment of the application; and
3. Confidentiality will be upheld throughout the review process.
Scope of expression of interest
SAHPRA and WHO are inviting South African vaccine manufacturers to participate in the pilot, which intends to streamline the registration process of locally made vaccines.
The call for EOI is open for candidate vaccines that appear on the National Department of Health list of priority vaccines, which are as follows:
1. Hexavalent (DTwP – HepB – Hib – IPV)
2. Pneumococcal Conjugate Vaccine (PCV)
3. Human Papillomavirus (HPV)
The vaccines are to meet the WHO TPP (target product profile) and the dossier to be submitted must be available in eCTD format as specified in the SAHPRA guideline.
Interested applicants must submit their expression of interest to the SAHPRA CEO through newmeds@sahpra.org.za
The motivation should include:
a) Name of the product
b) Applicant details and Responsible pharmacist details
c) Description of the vaccine, presentation, indication
d) Motivation of why they should be considered for the pilot
Successful candidates may be contacted for a pre-submission meeting which involves determining submission date, data package availability, GMP status of facilities.
For further information please contact Tammy Gopal at tammy.gopal@sahpra.org.za
Responses are to be sent to newmeds@sahpra.org.za by 15 January 2026.