REGULATORY REQUIREMENTS FOR APPROVAL OF OVER THE COUNTER DRUGS AS PER AUSTRAILIAN (TGA) GUIDELINES

The Therapeutic Goods Administration is a Commonwealth Government agency that regulates medical devices and drugs. Prescription medicines and over-the-counter medicines which meet Australian standards of quality, safety and efficacy are included on the Australian Register of Therapeutic Goods. Non-prescription or OTC medicines are considered to be ‘low risk’ in comparison with prescription medicines. They are evaluated for quality, safety and efficacy by the TGA and the Medicines Evaluation Committee, in accordance with the Australian Regulatory Guidelines for OTC Medicines, 1 July 2003 before they may be registered on the ARTG. TGA is monitoring the all aspects for drug approvals and monitoring the human health. As per the TGA act all the medicines are classified in to prescription, non-prescription medicines and export only medicines. TGA act states those medicines require registering or listing at TGA. Registration and listing requirements are based on the level of risk. All prescription and some non-prescription medicines are required to register at TGA and some non-prescription medicines and export only medicines are need to list at TGA. TGA has adopted the most of the EDQM guidelines for medicines. Post marketing activities of the TGA include investigating reports of problems, laboratory testing of products on the market, and monitoring to ensure compliance with the legislation. Keywords: TGA, ARTG, OTC, Non-prescription