For Listed and Over The Counter Medicines, Medical Device, New Substance and IVD companies looking to expand in the Australian market, obtaining regulatory approval from the Therapeutic Goods Administration (TGA) is an essential first step. The TGA thoroughly evaluates all therapeutic goods to ensure their safety, quality and efficacy before they can be supplied in Australia.
However, navigating the complex TGA regulations and approval processes can be incredibly challenging, time-consuming and resource-intensive without the right guidance and expertise. This is where leveraging experienced TGA consultants can make all the difference.
DTS provides exceptional TGA consulting services to assist manufacturers and suppliers with every step of the submission and approval process. Their dedicated team offer unparalleled insights into TGA compliance, act as the Australian sponsor, manage submissions, and ensure both an efficient and successful path to regulatory approval.
Overview of Australia’s TGA Regulatory Body
The Therapeutic Goods Administration (TGA) is the regulatory body responsible for evaluating and monitoring the safety, efficacy and quality of all medicines and medical devices supplied in the Australian marketplace.
The TGA regulates the following types of therapeutic goods:
- Prescription medicines: Innovator, generic, biosimilar
- Over-the-counter medicines
- Complementary medicines: Vitamins, supplements, homeopathic medicines
- Biologicals: Vaccines, cellular therapies, blood products
- Medical devices and IVDs
Depending on the product type, there are varied TGA regulations pertaining to safety, efficacy, manufacturing quality, labelling, post-market surveillance and more that companies must comply with.
Challenges of TGA Compliance
For manufacturers and supplier’s interpreting and meeting TGA’s regulatory requirements can be a complex task. Key challenges include:
- Unfamiliar regulations: Lack of experience with Australia-specific regulations, clinical trial requirements, product labelling standards.
- Extensive documentation: Compiling all necessary data, documents and clinical evidence required for different types of TGA submissions.
- Multi-format submissions: Preparing dossiers in the CTD format and eCTD format, which differ from other regulators.
- Language localization: Translating documents such as packaging and labels into English for the Australian market.
- Short timelines: Strict timeframes imposed for responses to TGA queries or requests.
- Limited resources: Finding personnel with capacity and right expertise in-house to focus on Australian regulatory compliance.
- Keeping up with changes: Monitoring and adjusting to frequent updates to TGA guidance and policies.
The lengthy TGA review process can mean years-long delays for securing market access if submissions lack the rigor, organization and polish needed to pass TGA assessments – resulting in multiple rejects and requests for additional data.
Consulting Services to Streamline the Path to TGA Approval
DTS provides end-to-end TGA consulting services covering every step from initial regulatory strategy through to post-market compliance:
- Upfront Planning and Preparation
- Regulatory advice: Provide guidance on ideal regulatory pathway based on product specifics. Recommend time and cost estimates for approval.
- TGA submission planning: Devise submission strategy, define required data packages, assist with dossier structuring.
- Clinical trial support: Ensure clinical studies meet TGA requirements for robust data.
- Review manufacturing process and controls to identify any gaps that could delay approval.
- Submissions to TGA for Approval
- Navigating Approval Process
DTS’s Experienced TGA Consultants Equip Companies for Success
To overcome the regulatory hurdles of bringing therapeutic products into Australia, life sciences companies need experts by their side who know the TGA system inside out. DTS offers this deep expertise in the form of specialist TGA consultants ready to guide clients through the process from start to finish.
