Archive

Submission of documents relating to an APIMF for [Name of API] [SAHPRA APIMF number, if allocated]...

Position Paper
Proposal to Applicants for Dossier Processing Fee - SADC MRH Collaborative Registration Procedure Initiative - A stepwise approach to increased efficiency and effectiveness

As the initial step to improve efficiency, the SADC Medicines Regulators Forum is proposing a semi-centralised approach to the joint...

This guide is intended to provide guidance to applicants on Good Review Practices. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. It is not intended...