Australia regulations

As mentioned above, UVA not only contributes to the erythema reaction of human skin, but beyond this effect creates further damage to the skin, e.g. DNA mutations.For this reason, the European Commission recommended a minimum requirement for the UVA protection of sunscreens in 2006. In Japan and Australia regulations for the assessment of protection against UVA already existed about a decade earlier.Up to date quite a number of methods have been developed and used for the assessment of protection against UVA, in vivo and in vitro, which have been comprehensively overviewed. Recently a certain consolidation took place through the work of ISO (International Standardization Organization, TC 217, WG 7). ... 

K. Chan Australia Regulating complementary and alternative medicines... 

Civil Aviation Safety Authority (Australia) regulations—notice of proposed rulemaking part 119... 

The following countries also have evaporative emission regulations Canada, European Economic Cormnunity (EEC), Japan, Brazil, Mexico, Australia, South Korea. Regulations in these countries have requirements that are typically less stnngent than the U.S. imperatives. Table 1 depicts the chronology of evaporative emission regulation developments in the United States. 

The consumer movement, particularly the Consumers Health Fomm, also has considerable political influence. As a result of political pressure exerted by HIV/AIDS pressure groups and industry, the DRA was reviewed, new legislation introduced and new committees established to ensure that the regulatory authority responded more efficiently to public and political needs. Professional associations, especially the Pharmacy Guild of Australia, have traditionally played an active role in decisions related to pharmaceutical regulation. The Australian Pharmaceutical Advisory Council was established by the Australian Government to advise the Commonwealth Minister for Health on pharmaceutical policy. 

In terms of the influence exerted by the public and the private sectors on dmg regulation, these 10 countries can be placed along a continuum, as depicted in Figure 3.3 below. Cuba, where the Government has exclusive power over regulatory decisions, is at one extreme, and Australia, where consumers and the pharmaceutical industry have official representation and make recommendations to the TGA, at the other. 

From Figure 3.4a it is clear that Australia has a large number of manufacturers to regulate, as do Malaysia and the Netherlands. This means that these countries will require a larger number of GMP inspectors compared with Cyprus, Estonia and Uganda, countries with a relatively smaller domestic manufacturing industry. 

Figure 3.4b, on the other hand, shows that the total number of drug suppliers (importers and wholesalers) and retail outlets to be regulated are higher in Malaysia and Venezuela, followed by Australia, than in countries such as Cyprus, Estonia, Uganda and Zimbabwe. 

Prescribing practice is the least widely regulated activity. It is regulated in six of the 10 countries, namely Australia, Cuba, Estonia, Malaysia, Venezuela and Zimbabwe. 

In many countries, the national dmg policy defines public policy relating to the pharmaceutical sector, including regulation. However, of the 10 countries studied, only four (Australia, the Netherlands, Uganda, Zimbabwe) have a written national dmg policy document. 

Countries that developed their dmg regulation more recently generally began with one or more relatively comprehensive pieces of legislation, which covered a larger number of fiinctions relating to control of the pharmaceutical sector than legislation developed earlier. The dmg laws of Australia, Malaysia and Zimbabwe are examples of such development. 

As mentioned above, significant changes in dmg regulation in Australia, Cypms and the Netherlands, were made as a result of the thalidomide disaster that occurred in Europe in 1961. This is a classic example of a crisis-led change. The disaster increased public concerns about pharmaceutical safety governments responded by imposing more stringent controls on the pharmaceutical sector, and with less resistance from the industry than would normally have been the case. 

Differences in the systems used to regulate clinical trials in Australia and the Netherlands illustrate how the delegation of authority affects the ability of the central agency to monitor the working of the entire system. In Australia, all approved clinical trials must be notified to the TGA. There is no such reporting requirement for the MEB in the Netherlands. Information about the number and details of clinical trials conducted in the Netherlands is therefore not readily available to the MEB. 

Secondly, stmctural features in dmg regulation in countries operating a federal system of government affect the ability of the DRA to monitor dmg distribution throughout the entire country. In Australia, authority over distribution channels is fully delegated to the individual states. As a result, the TGA does not have the authority to assess and control the dmg distribution situation for the whole country. In contrast, the Pharmaceutical Services Division in Malaysia appoints a deputy director of health in each of its 13 states with power to issue licences, carry out inspections and submit reports. Under this arrangement, command and control may be exercised and an official channel established for information flow between the federal and state governments. 

This study has found that dmg regulation does not meet these requirements in all the countries studied. In some countries, legislation omits or exempts certain areas of pharmaceutical activity from the scope of control. In Australia, Malaysia and the Netherlands, legislation requires traditional/herbal medicines to be assessed and registered. But this is not the case in Cypms, Uganda or Zimbabwe. As a result of such gaps, dmg regulation provides only partial protection for consumers. 

---