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Drug Registration in Australia


Since the 1960's, all new drugs introduced into Australia have been evaluated by the Australian Drug Evaluation Committee (ADEC). Developers and manufacturers of new medications provide ADEC with data regarding the drug's development, testing, safety and efficacy, as well as comprehensive details of the standards of manufacturing, labelling and packaging.

When ADEC is satisfied that the drug is safe, it is authorised for sale. Even though overseas health departments such as the European Drug Evaluation Committee and Federal Drug Administration (FDA) in the USA may approve a drug for sale in their own countries, all medications sold in Australia must also be approved via ADEC.

Drugs are further classified by the Poisons Schedule as:
S8 Drugs of Addiction, cannot be advertised to the public
S7 Specialist only, Prescription Authority required, cannot be advertised to the public
S4 Prescription required, cannot be advertised to the public
S3 Pharmacist recommendation, cannot be advertised to the public
S2 Over the Counter sales, can be advertised
Unscheduled Open sales in pharmacy or supermarket, advertising permitted

The ultimate availability and cost of the medication is further subject to the commercial and marketing interests of the manufacturer.

Application may be made under the Pharmaceutical Benefits Scheme(PBS) for a PBS Listing, effectively a subsidy for drugs deemed beneficial to the health of the community, which provides these medications at a reduced cost for the consumer and at an even lesser cost for pensioners and health care card holders etc.

Advertising of drugs to prescribers (doctors) and the public is monitored by the Australian Pharmaceutical Manufacturers Association (APMA) and Proprietary Medicines Association of Australia (PMAA) who interpret the Therapeutic Goods Act on behalf of the Therapeutic Goods Administration (TGA).

   


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