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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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The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

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