South Africa’s (SAHPRA’s) updated Reliance Guideline for a New Registration or Variation Application

This guideline is intended to provide information and guidance to applicants/HCRs on the prescribed requirements and process to be followed, in cases where a new registration or variation application is submitted to SAHPRA with the applicant/HCR requesting a reliance-based evaluation.

The World Health Organisation defines reliance as “[t]he act whereby the regulatory authority in one jurisdiction may take into account and give significant weight to – i.e. totally or partially rely upon – evaluations performed by another regulatory authority or trusted institution in reaching its own decision.

The relying authority remains responsible and accountable for decisions taken, even when it relies on the decisions and information of others.” Wherever possible, SAHPRA will leverage these pathways, relying on the evaluation efforts of Recognised Regulatory Authorities (RRAs) in order to reduce evaluation times.

Reliance-based evaluation pathways for medicines applications for new registrations and variations in South Africa will follow one of three evaluation / review pathways:

a) Abridged review

b) Verified review

c) Recognition

For more information click on this LINK