WHO TRS 929, 2005 Annex 5


WHO TRS (Technical Report Series) 929, 2005 Annex 5

Guidelines for registration of fixed dose combination medicinal products - Annex 5

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1. Scope 

2. General considerations 

3. Definitions 

4. Scenarios 

5. Balancing the advantages and disadvantages of a new fixed dose combination 

6. Data requirements for marketing authorization of fixed dose combination finished pharmaceutical products 

7. Product information or summary of product characteristics for fixed dose combination finished pharmaceutical products 

8. Post marketing studies and variations 


Appendix 1  Guidelines for co-packaged fixed-dose combinations 

Appendix 2  Principles for determining whether data from the scientific literature are acceptable 

Appendix 3  Pharmaceutical development (or preformulation) studies 

Appendix 4  Superiority, equivalence and non-inferiority clinical trials 


The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. They are being used in the treatment of a wide range of conditions and are particularly useful in the management of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), malaria and tuberculosis, which are considered to be the foremost infectious disease threats in the world today.

FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio of doses has been shown to be safe and effective, and when all of the actives contribute to the overall therapeutic effect. In addition there can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects, but such claims should be supported by evidence.

WHO TRS (Technical Report Series) 929, 2005 Annex 5

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