TGA Australia updates guidance on drug approval applications

Following changes to regulatory procedures, the Therapeutic Goods Administration (TGA) have revised their guidance on the mandatory requirements for effective approval applications. The updated version of the guidance covers details of the new priority review pathway and how to make filings based on reports from regulators overseas.

The guidance provides a breakdown of all the information companies need to give when filing for approval of a medicine in Australia. TGA has updated the guidance to incorporate comparable overseas regulator (COR) report-based applications and priority review submissions, which have recently been established, as they are slightly different to other types of filing.

Both processes are affected by good manufacturing practice (GMP) evidence requirements. If sponsors decide to take the COR approach, the TGA has advised that sponsors include evidence of GMP compliance or proof that they have applied for GMP clearance and paid the required fees for every production plant. The advice can also be applied to companies that want to receive priority review.

The guidance also covers the necessary components of priority review submissions. TGA states that applicants should include a copy of their priority review determination letters. Furthermore, if the applicant wants to be eligible for a waiver of section 23 submission fees, then it is advised that they send a copy of the orphan drug designation.

Additional changes to the guidance include removal of the details regarding category 2 submissions; the category shortened the regulatory review process for drugs that had already been approved in two “acceptable countries”.

To view TGA’s updated guidance on drug approval applications, please click here.