Regulatory Services in Australia

Looking for Expert Regulatory Affairs Consulting for TGA Registration? The Therapeutic Goods Administration (TGA) of Australia plays a critical role in ensuring the quality, safety, and efficacy of medicinal products and medical devices in the country. As one of the key regulatory authorities, the TGA mandates that all medicinal products, including devices, must be listed, registered, or included on the Australian Register of Therapeutic Goods (ARTG) unless exempted. The ARTG serves as a comprehensive database, listing essential details like product names, active ingredients, categorization, sponsors, and manufacturers.

The TGA regulates medicinal products and medical devices through a combination of pre-market assessments, post-market monitoring, and enforcement of Good Manufacturing Practice (GMP) standards. It ensures that Australian manufacturers are licensed and that overseas manufacturers comply with Australian standards. The TGA’s guidelines and regulations are pivotal for manufacturers, sponsors, suppliers, and other stakeholders in the drug development pipeline.

To prevent delays in the TGA registration process, the TGA conducts GMP inspections alongside registration reviews. Furthermore, the Australian Drug Evaluation Committee (ADEC), a team of medical professionals, provides external evaluations, offering advice on the suitability of marketing drugs in Australia. Ultimately, the TGA makes the final decision regarding market authorization after considering all available information and expert guidance.

Manufacturers, sponsors, and suppliers may face challenges due to the stringent and varying TGA registration requirements for products intended for the Australian market. With a deep understanding of these complexities, DDReg offers comprehensive regulatory affairs services in Australia to guide you through every phase of the regulatory process.