Snapshot

The Reliance-based Evaluation Pathways – ABRIDGED REVIEW 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 are to be registered using an abridged review pathway. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

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

Target time assessment is 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 an 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. SAHPRA’s timelines for the evaluation of applications submitted under the collaborative review pathways are as follows: - WHO Prequalification (WHO PQ): 90 working days - WHO SRA Collaborative Registration Procedure (WHO SRA CRP): 90 working days - African Medicines Agency (AMA): 90 working days - Marketing Authorisation for Global Health Products (MAGHP): 90 working days - ZAZIBONA Collaborative Procedure: 90 working days - EU-M4ALL (EU Medicines for All): 90 working days The evaluation timeline for applications qualifying for the abridged and verified review pathways is 200 working days. Note: The timelines indicated above exclude the period allocated for technical screening and the time during which the application is with the applicant for response..