Snapshot

The Registration of Candidate COVID-19 vaccines pathway has been developed by the South African Health Products Regulatory Authority (SAHPRA) of South Africa.

This pathway can be used where This pathway is for candidate COVID-19 vaccines..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

SAHPRA will allow for the filing of submissions for rolling review. This will allow SAHPRA to review data from early development while later-stage clinical trials are taking place. This strategy will help to expedite the regulatory review process for candidate Covid-19 vaccines. Before filing an application for a rolling review, applicants are to have gathered a certain level of evidence on the safety, quality and efficacy of their vaccine. Applicants should consult with SAHPRA before filing an application for rolling review. To file an application for a rolling review, applicants should at least provide the following: • Non-clinical and clinical trials phase 2 data that demonstrate promising evidence of safety and efficacy; • Written confirmation that phase 3 trials have started and there are enough people enrolled to provide evidence of safety and efficacy within a reasonable amount of time (expected to be within 6 months from initial filing); • Evidence which shows that manufacturing of the candidate vaccine is in compliance with good manufacturing practices (GMP) and that product quality and consistency are well controlled; • A submission plan giving the anticipated timelines for submitting the various components of the application. A preliminary submission plan should be included in the initial filing. NB: SAHPRA may on a risk-based analysis engage with the available data in terms of its acceptability with respect to quality, safety and efficacy. In an effort to avail vaccines for Covid-19 to the public expediently, it may be necessary to consider registration on the basis that the outstanding information be submitted within a prescribed timeline. The conditions will be reflected in a conditional registration.