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South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH

Recently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information Guideline" and "Quality and Bioequivalence Guideline".

SAHPRA will align certain medicine policies and procedures with those of the EMA, which comply with the ICH framework, in order to reflect global best practices for regulating health products with regard to safety, quality, and efficacy.

This guideline is intended to provide recommendations to applicants wishing to submit new registration applications as well as variations. SAHPRA has adopted the EU variation classification guidelines for orthodox human and veterinary medicines in full but with specific exceptions.

Click this LINK to know more about the list of adopted guidelines that should be referred to for quality and bioequivalence requirements for new registrations and variations as per SAPHRA.

The purpose of this guideline is to offer guidance to individuals or organizations seeking to submit applications for the registration of medicines. 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 guideline is relevant only to human medicines, including biological and complementary medicines, and describes the information required for the registration of “medicines” and for an application to amend a registered medicine. Medicines applications for new registrations and variations in South Africa will follow one of four evaluation/review pathways:

  1. Full review

  2. Abridged review

  3. Verified review

  4. Recognition

Submission of new applications in eCTD (electronic Common Technical Document) format is mandatory.

In order to understand the complete Evaluation Pathways, Expedited review process,Fees, Variations and etc, click this LINK.


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