Guidelines for Submission of Plasma Master File

These guidelines provide recommendations for manufacturers seeking to submit Plasma Master Files to support the quality of the starting materials for Plasma-Derived Medicinal Products (PDMP). These apply to applications for the registration or variations of PDMP. These guidelines emphasise the South African Health Products Regulatory Authority’s(SAHPRA) commitment towards the safety, efficacy, and quality of medicines. SAHPRA reserves the right to request any additional information to establish the safety, efficacy, and quality of a medicine in keeping with the latest knowledge at the time of evaluation. Alternative approaches may be used, but the knowledge that would have been utilised to inform a decision should be scientifically and technically justified. SAHPRA is committed to ensuring that all registered medicines will be of the required safety, efficacy, and quality. Applicants must adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.