1 min read
What is the Australian Register of Therapeutic Goods (ARTG)?
The Australian Register of Therapeutic Goods (ARTG) is a comprehensive database maintained by the Therapeutic Goods Administration (TGA), which oversees the regulation of therapeutic goods in Australia. It serves as a central registry for all medicines, medical devices, biologicals, and other therapeutic products that are lawfully supplied in the country.
Purpose and Importance of the ARTG
The ARTG ensures that therapeutic goods meet stringent safety, quality, and efficacy standards before they can be marketed and distributed in Australia. Every product listed on the ARTG has undergone a thorough evaluation process, providing healthcare professionals and consumers with confidence in their safety and effectiveness.
Who Needs to Register with the ARTG?
Any sponsor (manufacturer, importer, or distributor) intending to supply therapeutic goods in Australia must register their products with the ARTG. This includes:
- Prescription and over-the-counter medicines
- Complementary medicines (e.g., vitamins, herbal supplements)
- Medical devices
- In vitro diagnostic devices (IVDs)
- Biological products
The Registration Process
The ARTG registration involves multiple stages, including:
- Classification Assessment: Determining the product category based on risk level.
- Data Submission: Providing evidence of quality, safety, and efficacy.
- Regulatory Review: Comprehensive evaluation by the TGA.
- Approval and Monitoring: Post-market surveillance to ensure ongoing compliance.
Why Partner with Freyr Solutions?
Navigating ARTG registration can be complex and time-consuming. Freyr Solutions offers end-to-end regulatory services to streamline your registration process, ensure compliance with TGA regulations, and accelerate your product’s market entry. Our experts provide tailored regulatory strategies, dossier preparation, and post-market support.
Ready to enter the Australian market with confidence? Connect with Freyr Solutions today!