South Africa released Guidelines – How to Submit EOI to SAHPRA on WHO Collaborative Registration Procedure

The South African Health Products Regulatory Authority (SAHPRA) has released guidance inviting applicants to submit Expressions of Interest (EOIs) for the evaluation of medicines through the World Health Organization (WHO) Collaborative Registration Procedure (CRP). This initiative is intended to expand access to safe, effective, and high‑quality medicines across the Southern African Development Community (SADC) region by leveraging WHO’s scientific assessment work.

Overview of the WHO Collaborative Registration Procedure

The WHO CRP is a mechanism that enables collaboration between National Regulatory Authorities (NRAs), such as SAHPRA, and the WHO Prequalification Team (WHO/PQT). The procedure allows NRAs to utilize WHO’s scientific evaluations to strengthen their own premarketing assessment and registration systems. 

For pharmaceutical products, the process complements the existing WHO/PQT collaborative procedure with NRAs involved in inspection-related activities.

EOI Submission Process

Applications submitted to SAHPRA for evaluation under the WHO CRP must include a formal agreement allowing WHO/PQT to share relevant assessment information with SAHPRA. All shared information will be handled confidentially in accordance with applicable laws and established agreements.

Applicants expressing interest in the collaborative mechanism must submit the following, in line with SAHPRA requirements:

• A covering letter clearly stating the applicant’s intention to participate in the CRP 
• A product dossier in CTD format 
• Product samples 
• Site Master File (SMF) 
• Any additional country‑specific requirements, including: 
  • Application fees 
  • Completed statutory forms 
  • South Africa‑specific labeling requirements 

Required Documents

1. Covering Letter (in English), including: 

1.1 Statement of interest in participating in the CRP 

1.2 Confirmation that the product information submitted is “true and correct” 

1.3 Confirmation that the same dossier and data have been submitted to WHO/PQT 

1.4 Consent to share product‑related information with WHO/PQT and designated experts involved in the process, all of whom are bound by confidentiality agreements 

1.5 A completed and signed Appendix 3 as provided on the WHO website

These guidelines aim to streamline regulatory pathways, reduce duplication of effort, and acce