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. The types of medicine include a new medicine for a new chemical entity (NCE) including clones, a multisource (generic) product including replicas, a product line extension, a biological medicine, and a complementary medicine.

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

90 calendar days (excluding applicant's time).