May 26, 2021    Categories
Industry News Regulatory Affairs

Licensing products for Australia – A regulatory perspective

In a world of globalisation, in-licensing and acquisitions of pharmaceutical products is a common occurrence. In fact, to facilitate global development and harmonisation, TGA has adopted numerous scientific guidelines[a] and recognises evaluations of many jurisdictions with standards similar to its own, such as EMA, FDA, MHRA, PMDA, Health Canada and SwissMedic[b].

When it comes to licensing products, commercial drivers such as the market size, landscape and patient need, provide significant imperatives for decision making. However regulatory acceptance of the product dossier is equally as important to ensure commercial drivers can be achieved, otherwise these acquisitions risk being a costly, time consuming exercise.

Here we have a closer look at what are the key considerations for regulatory professionals to keep in mind when screening dossiers for potential licensing opportunities.

General dossier requirements

The first factor to consider is whether your dossier is in eCTD or NeeS format. While TGA currently accepts both, from 1 November 2021 TGA will begin a staged transition to eCTD only for prescription medicines. However companies are already increasingly moving towards eCTD. Whether in eCTD or NeeS, it is important to ensure that technical validation is successful with no errors and minimal warnings in order for the dossier to be accepted[c].  

If the dossier is eCTD Regulatory professionals should check the following to avoid validation issues:

  • When was the dossier was converted to eCTD (if applicable) is a baseline sequence (0000) available?
  • Has the dossier been regularly maintained?

Dossier details

When screening the licensed dossier, consider the following questions to assess the overall details of the dossier:

  • Which country is the dossier referenced from?
  • When was the dossier approved in this country? Are you reviewing the same version?
  • If it is an old dossier if yes:
    • How old is it?
    • Have there been any updates since? Are these changes relevant to Australian registration?
    • Do you have the data to support any updates i.e. has the dossier been kept up to date?
  • What other countries are you looking to register in, apart from Australia?

These questions are one step in the process of informing which registration pathway the dossier may be appropriate. For example the standard new medicine registration pathway, or expedited review pathways such as provisional, priority and Comparative Overseas Regulator report based review (COR A or B process) or working-sharing arrangements via ACCESS (Australia, Canada, United Kingdom, Singapore and Switzerland consortium).

Dossier content

When it comes to reviewing the dossier content, there are a number of things to consider from a TGA compliance and scientific point of view. These include:

  • Compliance with TGA’s mandatory requirements for an effective application[d] for prescription medicines, which includes details of aspects such as:
    • Batch analysis and stability data:
      • Is data available on 3 batches per strength? If not are there relevant justifications (e.g. bracketing approach) and/or commitments?
      • Is stability data up to date? Does it comply with the TGA’s stability guidelines?
    • Applicable manufacturing and process validation requirements
    • Sterility and microbiological requirements
    • Drug substance data requirements
    • Bioequivalence requirements, where applicable
    • Safety requirements including Pharmacovigilance and Risk Management Plan
  • Compliance with scientific guidelines – TGA has adopted and closely aligns with requirements contained in many relevant EU, ICH and FDA guidelines, which assist Sponsors to meet the legislative requirements for registered medicines.
  • Compliance to, or justification for method equivalence data, for any relevant official standards i.e. USP, EP, BP – this applies to analytical methods, drug substance or drug product monographs and container closure systems
  • Relevance of clinical data in the AU context i.e. does clinical data represent Australian population?
  • Are the proposed indications the same as those in the reference country?
  • Are the same manufacturing sites proposed in Australia as the reference country?
    • Is relevant GMP evidence available?
    • If additional sites are proposed is relevant data (e.g. manufacturing process, validation, batch analysis and stability data, GMP evidence) provided?

Not only do the answers to these questions inform the most appropriate registration pathway. They are critical in forming an in-depth gap analysis, providing a better understanding of the dossier quality and level of remediation and associated timelines that may be required before submission in Australia. Such level of information and analysis is critical to the success of the submission, overall launch plans and timings, with potentially significant commercial impacts.

As such it is always best to consider these factors during due diligence and negotiations so any issues can be discussed by both parties upfront.

At Global Pharma Solutions, we have been helping our clients with reviewing potential opportunities for 18 years. Understanding the critical nature and importance of commercial drivers, we help ensure that products will comply with Australian requirements and provide our clients with a clear path forward to getting their in-licensed products to market in the shortest possible time.

For further information and help with licensing products for Australia, please contact us at



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