Snapshot

The Reliance-based Evaluation Pathways - RECOGNITION pathway has been developed by the South African Health Products Regulatory Authority (SAHPRA) of South Africa.

This pathway can be used where Medicines for human use. .

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from Australia Canada EU-EMA Europe Japan Switzerland United Kingdom United States WHO Zazibona

Applicants are to provide SAHPRA with the intended evaluation pathways for Quality and Bioequivalence and Clinical evaluation, along with a brief motivation. The intended evaluation pathways should be indicated on the new registration/variation validation template in the relevant sections. Providing the intended pathways prevents unnecessary screening for reliance documentation in instances where a full review is intended by the applicant. Decisions related to an application’s final evaluation pathway and the extent of reliance on a RRA’s evaluation are fully at SAHPRA’s discretion and will depend on the availability and quality of reliance documentation submitted. SAHPRA will share screening queries with applicants regarding insufficient reliance documentation to ensure that as many applications as possible qualify for abridged and verified reviews. Where applicable, applications will default to a full review in the absence of a suitable reliance pathway. The target timeline for this recognition pathway is 90 calendar days.