Abstract
The Therapeutic Goods Administration (TGA), Australia’s regulatory agency, has codified its approach to the use of bibliographic data to support applications for the registration of new products and for variations to the registration of existing products through the development of a ‘points to consider’ document. The guidelines recognize the limitations of literature searching and the information contained generally within published papers and set out specific requirements for compiling and presenting bibliographic data. The TGA’s requirements, based on the principles of performing systematic reviews of the literature, and their impact are reviewed.
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