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TGA GMP Clearance Applications

In late May, Australia’s Therapeutic Goods Administration (TGA) announced that, in the face of a 60% jump in the number of GMP clearance applications since 2010, it has not been keeping up with its target approval timelines and is implementing a series of reforms in an attempt to shorten the process. TGA requested industry to […]

Australia to Adopt EMA Drug Quality Guidelines

In April, Australia’s Therapeutic Goods Administration (TGA) announced its intent to adopt ten European Medicines Agency (EMA) guidelines to replace portions of its own standards. The guidelines cover pharmaceutical quality, biosimilars, clinical safety and efficacy, and nonclinical standards.

Australia’s Reasons for Drug Application Rejection

TGA issued version 1.5 of its Australian Public Assessment Report (AusPAR) Guidance in mid-March. The AusPAR, published on the TGA website, includes information on the outcome of the evaluation process and the rationale for the decision to accept or to reject drug registrations.

Australia Changes Biosimilar Naming

In late January, Australia’s TGA made changes to its biosimilar naming convention in order to better match those used internationally. The agency’s former naming convention was based on WHO’s INN biosimilar identifier combined with the Australian biological name (ABN). TGA is reviewing its naming policy following a July 2014 WHO draft policy on biological qualifiers. […]

Australian Guidance on Release for Supply

Australia’s TGA issued a guidance on the batch release certification process for marketed medicines. The guidance consists of two parts: ● the general requirements for all manufacturers and sponsors, and ● examples of how the general requirements described in part one can be met for specific areas of manufacture.

Medicines Australia Opinion Paper on Regulatory Restructuring

Medicines Australia, a group representing Australia’s pharma industry, released a list of recommendations for the restructuring of the countries regulatory agency, TGA. The group recommends: ● increasing sharing activities with overseas agencies ● creating multiple approval pathways ● providing better IT capabilities ● removing unnecessary data requirements for pre-submission, and ● removing redundant requirements.

New Zealand and Australia Drop Plans for Joint Regulatory Agency

A joint statement was released by the health ministers of Australia and New Zealand to announce the end of efforts to establish the Australia New Zealand Theraputics Products Agency (ANZTPA). The decision followed a review of the progress and assessment of the costs to each country. The statement notes that the two countries plan to […]

APEC’s Assessment of Gaps in Supply Chain Regulation Reveals Surprising Differences in Country Approaches

The assessment by the Asia Pacific Economic Cooperation (APEC) organization of the gaps in the ability of regulatory agencies to address the problems of an international supply chain has revealed some surprising differences in their practices....

TGA joins EDQM’s CEP Assessment Process

EDQM announced in late June that its CEP Steering Committee has accepted the request from Australia’s Therapeutic Goods Administration (TGA) to actively participate in the assessment of applications submitted by manufacturers desiring a CEP. TGA has been accepting CEPs approved by EDQM for the past few years.

TGA Update on eCTD Submissions

In late June, TGA provided an update on the progress it has made in being able to accept electronic versions of common technical documents (eCTDs). The agency announced its agreement to purchase software in late February, and has since revised its Common Technical Document Module 1 to further its alignment with the European eCTD. TGA […]
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