PLEASE NOTE: This course has had a change of code - up to and including 2009 it was PHPH9104.

This course provides a general overview of ethical issues and laws relevant to the development and marketing of medicines. It includes the following topics: An Introduction to the Law and Administrative Law as it applies to the review of regulatory decisions provided by the Therapeutic Goods Act 1989 (Cth); and judicial review of other decisions.

Regulation of Medicines discusses regulatory principles regarding the use of developmental therapeutic products (medicines and medical devices) in human subjects and the risk/benefit considerations that are made by regulatory authorities worldwide when they consider whether a new product should be registered. Medicines can be further classified into prescription medicines and non-prescription medicines (including over-the-counter and complementary medicines). The organisation of the regulatory processes in Australia: the Therapeutic Goods Administration and advisory bodies are covered. Also dealt with are: preparation and submission of an application for approval to market a medicine or medical device and the relevant appeal processes; integration of regulatory affairs into the pre- and post-marketing planning and review of product development strategies; input from international bodies and national agencies. Regulatory access to unapproved medicines is discussed, including clinical trials and the Special Access Scheme in Australia. The course concludes with a description of the processes involved in registration of a medical device and the conformity requirements within Australia.

Note: The course is compulsory for programmes 7370, 5504, and 9060.