Regulation of Medicines in Australia

Introduction

All therapeutic goods on the Australian market are regulated, and this extends to medicines, medical devices, human blood, blood products and tissues. The Therapeutic Goods Administration (TGA) is the Australian Government department which is responsible for this. The purpose of national regulation of therapeutic goods is in order to ensure their safety and quality so as to protect the general public.

Australian Register of Therapeutic Goods

Any medicinal product that is to be legally supplied in Australia must be recorded on the Australian Register of Therapeutic Goods (ARTG). There are two classifications on the ARTG. Products are either ‘registered’ and assigned an AUST R number or ‘listed’ and assigned an AUST L number. The designation is decided by the TGA. Registered products are those which have been assessed for quality, safety and efficacy.

Such assessment follows TGA analysis of information required to be submitted by the manufacturer, including how the molecule was synthesised, the manufacturing procedure of the dosage form (and compliance with Good Manufacturing Practice), pharmacological and toxicological data from animal clinical trials, and human clinical trial data in relation to its proposed indication. These products include most prescription drugs in use today, vaccines, many common over-the-counter medicines and several complementary medicines for which there is sufficient evidence of their efficacy.

When new brands of generic medicines are released, they need to meet the same standards of quality and manufacturing, but only evidence of bioequivalence to the originator molecule is required rather than a full presentation of safety and efficacy data.

Listed products are those which have been tested for safety and quality but not efficacy, and so the manufacturer is limited to saying that the product “may” assist in managing or treating the condition it is marketed for. These medicines comprise of almost all other complementary medicines, such as vitamin and mineral supplements, herbal medicines, nutritional supplements, aromatherapy oils, and traditional medicines such as Chinese and Ayurvedic (Ancient Indian) medicines.

There is no expiry on registration except if the drug is removed from the market, or for a particular reason that has become evident. One such example is that of dextropropoxyphene where, after examination of the existing data, the TGA announced it would cancel registration of all pain-relievers containing dextropropoxyphene from the ARTG as of 1st March 2012.

The TGA based its decision on evidence that showed that the benefits of dextropropoxyphene as a pain-reliever did not outweigh the safety risks, as dextropropoxyphene can affect cardiac electrical activity in a dose-dependent fashion, increasing the possibility of severe arrhythmias. However, in accordance with the Therapeutic Goods Act 1989 the Australian sponsors of Doloxene and Digesic appealed for a review of the decision. Following the appeals process, the TGA remains with its decision to cancel the registration of the remaining products which is still to be effected. There was no such request submitted for Capadex and Paradex, so the registration of these products was consequently cancelled as of 1st March 2012.

Products That Are Not Regulated

There are certain medicines that do not require TGA regulation. These include any medicines dispensed or extemporaneously prepared for a particular patient, traditional Chinese medicine, or homeopathic products dispensed by such practitioners. Certain other products, for example those imported privately from overseas, are also not listed on the ARTG. If these products are required, they should be accessed via the Special Access Scheme (SAS), which permits the supply of such products for individual patients based on their particular case.

Essentially, the responsibility for prescription of an unapproved product belongs to the prescriber and the patient. Via this scheme, any product which is unapproved in Australia can still be accessed, except for drugs of abuse that have been forbidden by legislation. There are two streams which patients can be classified into:

• Category A: includes patients who “are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment”.
• Category B: includes patients who do not meet the Category A criteria.

Doctors are required to complete the appropriate application form depending on the definition their patient fits. Category A approval is immediate and does not require further TGA involvement, so doctors only need to submit the completed form directly to the pharmacy. Upon receipt of the form, the pharmacy will contact the supplier to place the order and when the supplier receives the form, the product is able to be released to the pharmacy.

For Category B patients, the completed form must be sent to the TGA for individual consideration and, if approval is granted, the TGA will then send the approval to the doctor to in turn be forwarded to the pharmacy. The supplier will again release the product to the pharmacy upon receipt of the TGA approval documentation.

Conclusion

The TGA provides a regulatory framework in order to ensure the safety and quality of therapeutic products provided in Australia, and to facilitate the accessibility and supply of unregulated products for patients. With the advent of internet shopping, the TGA faces a new set of challenges as products available for purchase from websites are not regulated by the TGA.

It is important that consumers are vigilant and consult their doctor and/or pharmacist prior to purchasing such products as one may waste their money, unintentionally breach legislation, or ultimately compromise their health.