RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > Australia’s TGA Clarifies Drug Approval Process in New Document

Australia’s TGA Clarifies Drug Approval Process in New Document

Posted 05 September 2014 | By Louise Zornoza

Australia’s TGA Clarifies Drug Approval Process in New Document

This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.

 

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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe

Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.