Australia’s TGA Clarifies Drug Approval Process in New Document

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Australia’s Therapeutic Goods Administration (TGA) this week issued a new question and answer (Q&A) guidance concerning the registration process for new prescription drugs, as well as how to make changes to an already registered product that involves clinical, nonclinical or bioequivalence data. 

The guidance, released on 3 September 2014, covers a wide range of questions, including one on the use of Section 31 (s.31) questions during the application process.

The consolidated s.31 is a single request for information, which brings together in one document all the questions that have been raised concerning the application from all of the relevant review units of the TGA. If a sponsor needs clarification as to any question in the s.31 document, a written request must be submitted to the TGA.