Snapshot

The EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase) pathway has been developed by the of South Africa.

This pathway can be used where pharmaceuticals, biological products, medical devices.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

For the purpose of joint assessment of applications for registration of biologicals (pilot phase), there will be two stages: 1. The first application(s) accepted to be submitted will undergo parallel assessment by both EDA and SAHPRA. 2. Later application(s) will undergo alternate assessment by EDA and SAHPRA where both authorities will divide the assessment work of the one submitted application among them. There will be alternate review and peer review of each regulator’s work. SUBMISSION STEPS. 1. The publication of an invitation to submit an expression of interest for pilot biological product evaluation project of EDA-SAHPRA Work Sharing Initiative. 2. Submission by the applicant to EDA-SAHPRA of an EOI to participate in this pilot procedure. 3. A pre-submission meeting with EDA-SAHPRA maybe requested after the submission by the applicant of an EOI. 4. A screening procedure to ensure that the dossier(s) submitted by the applicant as part of its EOI is complete. 5. Assessment of product dossier, which must include product data and information as specified in the applicable guidelines for submission. 6. The applicant submits the application for marketing authorization to both EDA & SAHPRA through each authority platform at the same time. 7. The application will be subjected to validation in 15 working days. 8. At the end of the validation step both authorities will discuss the findings. - When the validation requirements have been met/accepted the evaluation step (Day 0) will commence. - When the validation requirements have not been met, there will be requirements to be fulfilled by the applicant before the evaluation step (Day 0) can commence. 9. By day 75 the applicant shall receive any queries raised during the evaluation step by both authorities 10. The applicant has 60 working days to respond. 11. A single extension of 60 working days is accepted upon applicant’s request. 12. The response outcome will be shared with the applicant after 45 working days. 13. If there are any further queries the applicant has 60 working days to respond (last response round). 14. At day 180 the final reports for the evaluation process should be completed by both authorities.