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

The South African Health Products Regulatory Authority (SAPHRA) invites applicants to submit Expressions of Interest (EOIs) for evaluation of applications using the WHO pre-qualification collaborative registration procedure for to support access and affordability to quality, safe and effective medicines in the Southern African Development Community (SADC) region.

The WHO Collaborative Registration procedure is a process involving collaboration between National Regulatory Authorities – NRAs (i.e. SAHPRA) and WHO/PQT. It aims to provide a convenient tool for NRAs wishing to enhance their premarketing evaluation and registration system by taking advantage of the scientific assessment work conducted by WHO/PQT. For pharmaceutical products the present procedure is complementary to the WHO/PQT collaborative procedure with NRAs in inspection activities.

Procedure for the EOI:

Applications for evaluation of medicines via the WHO Collaborative Registration Procedure must be accompanied by a formal agreement that information may be shared by WHO PQT, with SAHPRA. The information will be treated as confidential, in line with applicable legislation and arrangements. In applying for product evaluation through the collaborative mechanism, applicants are requested to submit a covering letter (clearly indicating interest to participate in the CRP), product application in the CTD format, product sample and site master file, according to the SAHPRA requirements. The country-specific requirements include especially:

• Application fees;
• Statutory forms to be completed;
• Country specific labelling Requirements.

Documents to be Submitted:

1.     Covering letter, in English, expressing

1.1   Interest in participating in the CRP.

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

1.3   Confirmation that the same1 dossiers and data have been submitted to PQT;

1.4   Consent to sharing of the product related information, during registration and in post-registration period, with staff and with external experts, who support the process and are bound by confidentiality undertakings.

1.5   Completed and signed Appendix 3 as detailed on the WHO website