The South African Health Products Regulatory Authority published a guideline that 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 purpose of this guideline is to guide how medicines that are not yet available in South Africa may become registered for use by, or authorized for sale to, those who are affected by a Public Health Emergency (PHE).
PHEs represent a significant concern for their potential domestic and international impact. The unusual and unexpected nature of PHEs may lead to situations for which there is no or insufficient effective diagnosis, treatment, or prevention of the associated conditions, diseases, or disorders associated with the PHE.
The Authority, therefore, needs to consider mechanisms that would allow for the agile, expeditious and appropriate review of medicines required in a PHE.
The processes encompassed in this document guide how applicants may position their applications to best facilitate the review of applications for the registration, or authorization of the sale, of a qualifying medicine in response to a PHE.
The Authority is mandated to assess the safety, quality, and therapeutic efficacy of all medicines in determining whether the availability of medicine is in the public interest.
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