The Application Entry Team (AET) of the DSEB conducts an administrative screen of the application before the dossier is accepted for evaluation to ensure that there are no deficiencies that would render the application not evaluable. Following the receipt of the ADEC Resolution, the secretary or her delegate (the TGA Delegate) decides whether the application for registration is to be approved or rejected. The sponsor will be advised of the decision of the secretary or the delegate within 28 days of the decision being made.

If the TGA delegate proposes to approve the application, he or she will communicate with the sponsor to address any outstanding issues relating to the application. The TGA may contract external evaluators to review aspects of the data. A TGA delegate will coordinate the evaluation with the external evaluator. Communication with the sponsor in relation to an evaluation, for example issuing Section 31 questions, will be through the TGA delegate. The identity of external evaluators is generally kept confidential.

The registration process for imported drugs is slightly different in Australia as compared to domestic drugs with import drugs requiring import permits and quarantine clearance. Under the Customs (Prohibited Imports) Regulations, importers of narcotics, psychotropic medicines, anabolic steroids, growth hormones, antibiotics and radioactive substances must obtain an import permit and licence. An application for a licence to import should be made in writing to the head, Treaties and Monitoring Section, TGA. Licences are issued subject to Regulation 5 of the Customs (Prohibited Imports) by an authorised person from the TGA. Customs requirements can vary and it is the responsibility of the sponsor to keep abreast of requirements in relation to goods to be imported.

Importers of biological products are also advised to obtain clearance from the Australian Quarantine and Inspection Service (AQIS). All medicines must comply with legislative requirements in force in Australia. Statutory Standards under the Act include the Therapeutic Goods Orders (TGOs) determined under the Act and the British Pharmacopoeia (BP). Where no standard is specified in a TGO or the BP, or where a sponsor is able to demonstrate that the safety and quality of a product will not be compromised, the TGA may allow that the product meet either a standard specified by another pharmacopoeia, such as the US Pharmacopeia (USP) or an agreed non-pharmacopoeial standard.

(The above literature has been extracted from Australian regulatory guidelines for prescription medicines. To know more about regulatory-related issues in Australia, visit www.tga.gov.au)