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South Africa's (SAPHRA) Guideline for Fixed-Dose Combination Products

Earlier today (07-February-2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for Fixed-Dose Combination Products (FDC Products) for HIV/AIDS, Tuberculosis and Malaria".

The purpose of this guideline is to provide applicants with recommendations regarding FDC application submissions.

Fixed-Dose Combination Products (FDC Products) is defined as "A single product created by the combination of two or more active pharmaceutical ingredients (APIs) in a single formulation, and in which each API contributes to the benefit of the new product".

FDC products are not simply two single, distinct products packaged together. APIs can be pharmaceutical (i.e. chemical) or biological in origin.

Among the most prevalent infectious diseases, HIV/AIDS, tuberculosis, and malaria pose the greatest threat to public health. Combination therapy is therefore essential for treating these diseases and preventing resistance.

There should be in accordance with any specific technical guidance specified in the Guideline for Fixed-Dose Combination Products (FDC Products) for HIV/AIDS, tuberculosis, and malaria.

In addition to this guideline, SAHPRA may request any additional information necessary to ascertain a medicine's safety, quality, and efficacy given the current state of knowledge.

Click this LINK to know more about the general consideration of the clinical studies etc that need to adhere for approval.


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