Author

Marco Theobold

Director of Medical Device and Drug Services

Submitting Your Master Files to the Australian Therapeutic Goods Administration

Oct 17, 2023

The Therapeutic Goods Administration (TGA), part of Australia’s Department of Health and Ageing, is responsible for regulating medicines and medical devices nationwide. The TGA uses a mechanism called a Drug Master File (DMF) to allow sponsors to provide information about a drug substance sourced from third-party manufacturers.  

Similar to a Europe Medicines Agency (EMA) active substance master file (ASMF), a TGA DMF may be used by drug substance manufacturers to provide confidential product materials to TGA in support of their customers’ application without disclosing proprietary information.  

EMA vs. TGA Master File Submissions

Here are some important similarities and differences between EMA and TGA master file submissions: 

  • TGA prefers that manufacturers submit their DMFs in one of two formats: electronic Common Technical Document (eCTD) or Non-eCTD (AU) electronic Submission (NeeS) format. For eASMFs, the EMA requires all submissions to be in eCTD format unless they are for veterinary medications. 
  • In addition to EMA’s ASMF requirements, TGA requires further information for the following types of drug substance: drug substances with a default standard monograph, sterile drug substances, product of human and animal origin, and substances produced wholly or in part by fermentation.  
  • Similar to EMA ASMFs, annual reports are not required for ASMFs submitted to TGA. Instead, the master file is expected to be kept up to date with amendments as needed. 

TGA requires that the mast file holder request a client ID for the company and then an e-Identifier (e-ID) for the submission. It’s important that no validation errors are present when the sequence is checked by a validator program. If any errors cannot be eliminated, they must be justified in the submission cover letter. TGA will reject any submission with errors that haven’t been justified. 

Submitting Therapeutic Goods Administration Master Files

Properly submitting TGA DMFs can be a long and complicated process. However, using DMF Specialists like those at Registrar Corp assures that your DMF will be filed properly while also protecting your confidential intellectual property. Learn more about how Registrar Corp can help you submit your DMFs to TGA today. 

Author


Marco Theobold

Director of Medical Device and Drug Services

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.

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