Regulatory Services in Australia
Australia
The Therapeutic Goods Administration (TGA) of Australia monitors and evaluates the quality, efficacy, and safety of medicinal products and medical devices. Unless exempted, a medicinal product, including a device, must be listed, registered, or included on the Australian Register of Therapeutic Goods (ARTG) before they can be distributed within and from Australia. The ARTG contains important data such as a product name, active ingredients, categorization, sponsor, and manufacturer. The TGA regulates medicinal products through pre-market assessment, post-market monitoring and enforcement of standards, licensing of Australian manufacturers, and verification of overseas manufacturers’ compliance. It has established guidelines and regulations for suppliers, sponsors, manufacturers, and other contenders along the drug development pipeline to adhere to. The TGA conducts GMP processes in parallel to registration review procedures to minimize delays in the authorization process. Furthermore, the ministry appoints a team of medical professionals for external evaluation. This is the Australian Drug Evaluation Committee (ADEC) that provides advice on the suitability of marketing the drug in Australia. Ultimately, the decision for market authorization is taken by the TGA after careful consideration of information and external advice. Manufacturers, sponsors and suppliers may face challenges due to the different requirements set by the TGA for the registration of products that are intended to be marketed in Australia.
As a leading global contender, DDReg’s regulatory services in Australia provides on-going support and development of the customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.
DDReg Services include:
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- ICSR Processing and Submission
- Risk Management
- Aggregate Reports
- Signal Management
- QPPV Services
- Bio Waiver Justifications
- Clinical & Non-Clinical Experts Reports
- IPR Support, including Worldwide Patent Status and Patent Reviews