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Australia: TGA Updates Guide to Drug Approval Applications Following Regulatory Changes

Wednesday, February 21, 2018: The Therapeutic Goods Administration (TGA) of Australia has revised its guide to the mandatory requirements for effective approval applications following changes to its regulatory procedures. The latest version of the guide incorporates details of the new priority review pathway and how to make filings based on reports from overseas regulators.

The guide, which was first published in 2010, provides a breakdown of all the information companies need to provide when filing for approval of a medicine in Australia. As comparable overseas regulator (COR) report-based applications and priority review submissions work slightly differently than other types of filing, TGA has updated the breakdown to cover these recently established processes.

Good manufacturing practice (GMP) evidence requirements are affected by both processes. TGA is advising sponsors that take the COR approach to include evidence of GMP compliance or proof that they have applied for GMP clearance and paid the necessary fees for each production plant. TGA is making similar demands on companies that want to receive priority review.

The revised guide features other sections covering the mandatory components of priority review submissions. TGA also expects applicants to include a copy of their priority review determination letters. If the applicant wants to be eligible for a waiver of section 23 submission fees, it must also send a copy of the orphan drug designation.

In adding the section on COR report-based applications, TGA has removed details about category 2 submissions. The category shortened the regulatory review process for drugs that had already been approved in two “acceptable countries.”

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