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ARGOM Appendix 1: Guidelines on efficacy and safety aspects of OTC applications
9. Fixed combination products
The data requirements for supporting registration of fixed combination products are as described in the Guideline on Clinical Development of Fixed Combination Medicinal Products (CPMP/EWP/240/95 Rev1), which has been adopted by the TGA. An outline of requirements and issues to consider is included below, but the guideline should be consulted for full requirements. In general, data requirements for new composite packs containing multiple active ingredients are the same as those for fixed combination products.
The particular combination of active ingredients in a proposed new combination product must be justified. Each active ingredient must make a therapeutic contribution to the claimed indications and the product must provide rational concurrent therapy for a significant proportion of the target population. Where individual substances in the combination are intended simultaneously to relieve different symptoms of a particular disease state, these symptoms should regularly occur simultaneously in a clinically relevant intensity and for a relevant period of time. The dose and proportion of each active ingredient must also be appropriate for the intended use.
The safety and efficacy of the combination will need to be supported. The possibility of pharmacodynamic and pharmacokinetic interactions between the active ingredients must be considered. Clinical efficacy and pharmacokinetic data comparing the proposed product with the active ingredients used separately will usually be required. Refer to the above CPMP document for detailed guidance.
If an oral combination product is proposed as a generic of an existing combination product, then safety or efficacy data should not be required, except that bioequivalence data may be required. The requirements for bioequivalence data are the same as those that would apply for each active ingredient individually, as if they were the sole active ingredient (see 'Section 6.1 Bioequivalence data'). For example, bioequivalence data should not be required for a particular component active ingredient where, based on its inclusion in 'Section 11 Active ingredients for which bioequivalence data are not generally required', bioequivalence data would not be required if it was the sole active ingredient.
Where one or more component ingredients have modified-release characteristics, the guideline on modified-release products also applies.