Australia remains one of the important markets of the continent with major contributions to the healthcare and pharmaceutical industry. As a part of major revamping of the pharmaceutical sector and to align with the western world, the regulations governing medications and medical devices underwent significant change under the government directive in October 2014. The regulatory system since then has been involved in regulating drugs and biological products, medical devices as well as dietary supplements. All these products need to be listed following a detailed regulatory review process with the Therapeutic Goods Administration (TGA) Australia the apex national regulatory authority.
Manufacturers must get approval from the (TGA), Australia, before distributing or selling medicinal items or medications. For the registration, maintenance, and approval of pharmaceutical items in Australia, the TGA has specific regulatory requirements. Manufacturers and sponsors must stay up to date on the most recent TGA regulatory framework and Regulatory Affairs Australia requirements due to recent rules relating to labeling and submission formats. The Australian Register of Therapeutic Goods (ARTG), a database of data about therapeutic goods for humans that are “approved for supply in, or exported from, Australia,” was established as a result of the Therapeutic Goods Act of 1989. The TGA provides criteria for advertising, labeling, product appearance, and appeal as well as the specifications for inclusion in the ARTG. The typical approval process for this drug takes 240-260 working days.
The drugs that are listed in the database are either registered (i.e., higher risk drugs: prescription drugs, some over-the-counter drugs, herbal drugs, ayurvedic, traditional Chinese, Australian indigenous drugs, other complementary drugs, vitamins and minerals, nutritional supplements, homeopathic drugs, and aromatherapy products) or listed (i.e., lower risk drugs: some over-the-counter drugs, herbal drugs, ayurvedic, traditional Chinese, Australian indigenous drugs, other complementary drugs,). Each medication is given an AUST R number (registered) or an AUST L number (listed medications) when it is given marketing approval. For applications for admission or change of entry into the Australian Register of Therapeutic products (ARTG), which allows for the legal supply of therapeutic products in Australia, AusPARs are published. All applications relating to new chemical and biological entities and extensions of indications are included in AusPARs, which are typically only generated for applications where TGA has requested guidance from its Advisory Committee on Prescription Medicines (ACPM) before making a decision. In Australia, the clinical developmental studies and research programs should be in accordance with the ICH GCP guidelines. Therapeutic safety monitoring of medicines is an important aspect that is governed by the Australian drug regulations and TGA Australia runs several programs to study safety of medicines once placed in the market.
