Australia’s TGA Issues Amended Bioequivalence Guidance

Regulatory NewsRegulatory News | 10 July 2014 |  By 

Australia’s Therapeutic Goods Administration (TGA) has issued an amended bioequivalence guidance document applicable to all prescription medicines except for biologicals. 

The guidance includes European Union guidelines that have been adopted by the TGA, such as the investigation of bioequivalence, the quality of modified release dosage forms, modified release oral and transdermal dosage forms, and the clinical investigation of the pharmacokinetics of therapeutic proteins. 

The guidance is intended to assist sponsors of prescription medicines to prepare applications to register new prescription medicines, or vary the registration of an already approved prescription medicine.


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