TwitterLinkedin

Contact Us

  • Biopharma Excellence
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Integrated Product Development
            • Market Access
            • Scientific Advice
            • Statistics and Data Sciences
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Scientific Advice
            • Statistics and Data Sciences
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistics and Data Sciences
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • ICSR (Individual Safety Case Report) Management
            • Literature Monitoring & Screening
            • Pharmacovigilance Quality & Compliance
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • MedTech Services
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • COVID-19 Support
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Post-Brexit Regulatory Support
            • Statistics and Data Sciences
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Career Opportunities
  • Training
Home > News & Events > Blog > Keeping the genie in the bottle – managing genetically modified organisms (GMOs) in Australia

Keeping the genie in the bottle – managing genetically modified organisms (GMOs) in Australia

Both within Australia and internationally, concerns exist about the potential risks that gene technology may pose people and/or the environment. Consequently, there is a risk-based approach taken by legislators regarding the use of gene technology. Although genetically modified plants, seeds and animals are more commonly thought of when GMOs are mentioned, the technology is increasingly being applied to therapeutics.

What is gene technology?

Gene technology, as defined by the Gene Technology Act 2000 (GT Act), is any technique for the modification of genes or other genetic material and embraces a wide range of potential applications including medical and vaccine research, diagnosis and treatment of disease, environmental remediation, and the modification of plants and animals to incorporate new growth and compositional characteristics.

How is gene technology regulated in Australia?

In Australia, the Gene Technology Regulator (GTR) is responsible for protecting the health and safety of people and the environment by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs) consistent with the object of GT Act.

The GTR is an independent statutory office holder who, with the support of the Office of the Gene Technology Regulator (OGTR), is responsible for administering the GT Act and corresponding state and territory laws. All Australian jurisdictions contributed to developing the regulatory scheme and legislation to ensure national consistency.

A GMO (as defined by the GT Act) is:

  • An organism that has been modified by gene technology; or
  • An organism that has inherited traits from an organism, where the traits occurred in the initial organism because of gene technology.

Activities undertaken with GMOs are known in the gene technology legislation as ‘dealings’. Dealings with GMOs include conducting experiments with, making, developing, producing, breeding, propagating, growing, importing, transporting or disposing of GMOs. All dealings with GMOs are prohibited unless explicitly authorised under the GT Act.

The GTR accredits organisations to conduct work with GMOs, certifies containment facilities used for dealings conducted under the Act, and conducts monitoring and compliance activities and maintains a publicly accessible record of all dealings in Australia that involve GMOs (the GMO Record).

Who can apply for a licence to deal with GMOs?

The GT Act does not restrict who can apply for a licence, however in considering licence applications the Regulator must consider applicant suitability. Licence holders assume certain responsibilities and legal obligations as set out by the GT Act and the Regulator. Licences are usually issued to organisations operating in Australia, such as universities, hospitals or companies. Generally, licence conditions also require the licence holder to be accredited under the GT Act. If an organisation is not already accredited, it is possible to submit an application for accreditation at the same time as an application for a GMO licence.

What are GMO Medicines?

Medicines produced by genetic manipulation can be divided into two broad categories:

• Medicines derived or produced from GMOs (biological medicines).
• GMOs that are intended for use as medicinal agents (GMO medicines)

GMO medicines may include:

• live attenuated vaccines (viral or bacterial)
• viral vectors
• modified somatic cells

Sponsors that are intending to submit applications to the TGA for a GMO as a medicine or biological medicine (including use in a clinical trial) need to consult the OGTR to determine any obligations under the GT act. For medicines that contain or consist of GMOs or are manufactured in Australia and are derived from GMOs an approval/licence from the OGTR is required before the medicine can be used.

Genetically Modified Organisms vs Genetically Modified Products

Genetically modified (GM) products are products that are derived or produced from a GMO but which are not alive. Provided the therapeutic product does not contain viable GMOs, it is considered a GM product and is not covered by the GT Act. For example, a purified protein derived from a genetically modified bacteria is a GM Product and not covered by the GT Act, however, the bacteria responsible for producing the protein would be subject to the gene technology legislation for dealings undertaken in Australia.

The GTR does not directly regulate the use of GM products in Australia because the use of these products is usually overseen by other regulatory agencies in a number of situations. For example, while the Therapeutic Goods Administration oversees the use of GM products as human therapeutics. This arrangement avoids duplication of regulatory oversight.

Contact us
Related posts
Sponsors gear up for a smoother process with CTIS but must first overcome key hurdles
Sponsors gear up for a smoother process with CTIS but must first overcome key hurdles
2nd June 2022
Medical device software brings new complications around compliance
Medical device software brings new complications around compliance
30th May 2022
Is quality documentation an asset or a burden in regulatory affairs?
Is quality documentation an asset or a burden in regulatory affairs?
6th April 2022
Navigating the impact of the IVDR on marketed products
Navigating the impact of the IVDR on marketed products
24th March 2022
Minimizing risk during the transport of medicinal products
Minimizing risk during the transport of medicinal products
21st March 2022
Next Steps for EUDAMED implementation within MDR
Next Steps for EUDAMED implementation within MDR
7th March 2022
Recent Blogs
  • Sponsors gear up for a smoother process with CTIS but must first overcome key hurdles
    2nd June 2022
  • Medical device software brings new complications around compliance
    30th May 2022
  • Is quality documentation an asset or a burden in regulatory affairs?
    6th April 2022
  • Navigating the impact of the IVDR on marketed products
    24th March 2022
  • Minimizing risk during the transport of medicinal products
    21st March 2022
  • Next Steps for EUDAMED implementation within MDR
    7th March 2022
Recent News
  • Why collaboration and an Integrated Product Development program are key to successful drug development
    14th June 2022
  • Key Takeaways from the PDA Europe Annex 1 Workshop
    7th June 2022
  • Addressing Limitations of Sterility Testing
    9th May 2022
  • Are virtual audits sustainable post-pandemic?
    6th May 2022
  • Orphan Drug Designation: Securing the Significant Benefits
    28th March 2022
  • PharmaLex expands pricing & reimbursement and health economics platform with EBMA Consulting merger
    9th March 2022
Upcoming Webinars

July 28th, 2022

The regulatory and business importance of medical device post-market surveillance

09:00 AM CET

Biopharma Excellence Website Image

PharmaLex Brings You Biopharma Excellence

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

Visit Website
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
30 Jun

The #CTIS brings many opportunities, but it will also require a lot of process changes and preparation, find out more 👉https://lnkd.in/eZRqyPPX about the benefits and challenges with the CTIS.

➡  Take the @Phlexglobal #survey! https://lnkd.in/eA5FwHJC

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • Thanks so much for your support over the past 30 days. Your commitment and timely communication have made working with you all a pleasant experience.

    US Biotech
    Senior QA Associate
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from @pharmalex.com. Should you receive an email and are unsure as to its validity, please report it to contact@pharmalex.com.

Many thanks for your understanding.

The PharmaLex Team

    Please DO NOT send us event/conference information.
    We will not respond and these will be deleted immediately.






    Select your state:

    .
    If you do not wish to receive any communication from us, you may unsubscribe at any time.

    #AskTheExpert #TogetherBEYONDCOVID19





      Select your state:

      .
      You can unsubscribe at any time at data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      #TogetherBEYONDCOVID19

      We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for