Reference:
South African Health Products Regulatory Authority. (2019). Quality and bioequivalence guideline (Version 7).
Summary:
The Quality and Bioequivalence Guideline by the South African Health Products Regulatory Authority (SAHPRA) outlines the requirements for applicants submitting registration applications for new medicines and variations. It emphasises the need for safety, efficacy, and quality of medicines, aligning local practices with international standards set by the European Medicines Agency (EMA) and the International Council for Harmonisation (ICH). The guideline details various review pathways, including full and reliance-based evaluations, which allow SAHPRA to leverage assessments from recognised regulatory authorities. It also specifies documentation requirements and South Africa-specific conditions for drug products, particularly regarding stability and bioavailability studies. Applicants are encouraged to adhere strictly to these guidelines to ensure efficient processing of applications and to facilitate smoother market access for medicines.