PXL/HO/Cir-023/2022-23 Date: 21.06.2022
Dear Sir / Madam,
Subject: South Africa Registration Procedure for Medicines in Public Emergency
We are pleased to inform that the South African Health Products Regulatory Authority (SFHPRA) has issued an amendment effective 1st June 2022 w.r.t "Availability of Medicines for Use in a Public Health Emergency (Phe)”.The attached guideline provides recommendations to applicants who intend to submit applications for the registration or authorization of medicines intended to be available to those affected by a public health emergency.
The guideline represents the current position of the SAHPRA on approaches to determine the quality, safety, and efficacy of the medicines required in a public health emergency. However, the guidelines are not intended as an exclusive approach. Pharmexcil members may refer to the attached South Africa Registration Procedure for Medicines in Public Emergency dated June 2022. Alternatively, members may also view the same at www.sahpra.org.za.
Disclaimer:It should be noted that the SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine in keeping with the knowledge current at the time of evaluation. Member companies may also use alternative approaches, but these should be scientifically and technically justified. It is important that applicants also adhere to administrative requirements to avoid delays in the processing and evaluation of applications.