Australia prescription medicine

Australia s Therapeutic Goods Administration (TGA) has perhaps one of the most progressive and comprehensive regulatory systems in the world. Under the Therapeutic Goods Act, the TGA regulates prescription medicines, OTC... 

In June 2004 the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) were issued by the TGA to replace the AGRDl. Under the ARGPM the format for registration applications in Australia is the Common Technical Document (CTD) developed through the International Conference on Harmonisation (ICH). 

As previously mentioned, Australia has closely aligned its data requirements for the registration of prescription medicines with those of the European Union. The ARGPM describes certain... 

Submissions to register new prescription medicines in Australia undergo a two-stage process of evaluation by the DSEB - application acceptance and evaluation. 

The requirements for reporting adverse drug reactions to prescription medicines occurring in Australia or overseas are described in the Australian Pharmacovigilance Guidehne, which is available at the TGA website. 

In August 2003, the Department of Health and Medicines Australia, representing the prescription medicines industry, commenced a joint review of the listing processes post-PBAC. The review s main objective was to advise on any necessary post-PBAC (pPBAC) changes. .. which would improve the efficiency and effectiveness of the entire process in order to achieve earliest possible subsidised access for consumers to cost-effective medicines, while minimising the regulatory burden on industry. ... 

Prescription medicines may only be advertised to healthcare professionals - they may not be advertised to consumers. Advertisements of prescription medicines directed at healthcare professionals are regulated under a self-regulatory Code of Conduct administered by Medicines Australia. First published in 1960, it includes... 

Americans spent more on prescription drugs in 2004 than they did on gasoline or fast food. They paid twice as much for their prescription medicines that year as they spent on either higher education or new automobiles. Americans spend more on medicines than do all the people of Japan, Germany, France, Italy, Spain, the United Kingdom, Australia, New Zealand, Canada, Mexico, and Argentina combined.11... 

Cuba, Cyprus and Tunisia (1997), the rest (1998). Data for Australia inciude producers of prescription and+OTC products (inciuding compiementary medicines and medicai devices). 

In general, all new chemical entities or compounds not previously available in Australia are first classified as prescription-only medicines. In the light of experience and depending on their use, they may be made available as OTC medicines with gradually decreasing levels of controls. Procedures for switch submissions will be discussed later in this chapter. 

There is also a self-regulatory code of practice with supporting guidelines covering the promotion and advertising of prescription-only medicines, namely the Medicines Australia code of conduct. 

The Medicines Australia Code of Conduct is the self-regulatory body for the pharmaceutical companies in Australia. It has a Committee, which hears complaints relating to prescription-only medicines, and can impose sanctions on Medicines Australia members. This includes fines of up to AU200 000, corrective advertising, and suspension or expulsion of members. 

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