Medicines in Australia are regulated by the Therapeutic Goods Administration (TGA). The TGA has different pathways, data requirements, regulations and timelines for prescription medicines, over the counter medicines, and complimentary medicines. So how do I know my medicine type and what pathway should I use to include my medicine on the Australian Register of Therapeutic Goods (ARTG)?
The TGA has a risk-based approach to regulating therapeutic goods, this approach is designed to ensure regulation is only used where absolutely needed and then only to the extent needed to protect and advance public health.
All medicines are evaluated based on the evidence of their risks and the evidence of their associated benefits. The amount of regulation required depends on the nature and intended use of the medicine, and the level of risk ultimately determines the level of access the public can have to the medicine.
Prescription medicines
Prescription medicines carry the highest risk and are divided into two categories, Schedule 4 and Schedule 8 medicines. The Schedules are defined by the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). Both Schedule 4 and Schedule 8 medicines are evaluated via the prescription medicine pathway and have the same data requirements. However access to Schedule 8 medicines is more strictly controlled with restrictions around manufacture, supply, distribution and possession. Typically these are substances of abuse or misuse. Schedule 4 medicines are available via a prescription from a doctor.
All prescription medicines must be registered with the TGA following a detailed evaluation process.
Over-the-counter (OTC) medicines
OTC medicines are divided into three categories, Schedule 2 (pharmacy medicines), Schedule 3 (pharmacist only medicines) and general sales or unscheduled medicines. A schedule 3 medicine is a considered a higher risk OTC medicine and must be kept behind the counter of a pharmacy and sold with a pharmacists advice. A schedule 2 medicine must only be sold from a pharmacy but does not require advice from a pharmacist. A general sales OTC medicine can be sold in retail outlets such as supermarkets and petrol stations.
OTC medicines can be either registered or listed depending on their risk profile. A registered OTC medicine carries the highest risk in this category, and will require a similar data set to that required for a prescription medicine. A listed OTC medicines involves a different process; very few OTC medicines are listed. Regardless of whether they are listed or registered, once approved, OTC medicines are also included on the ARTG.
Complementary medicines
Complementary medicines are medicines that contain ingredients such as vitamins, minerals, herbs, aromatherapy or homoepathic preparations. There are three categories of complementary medicines, registered (higher risk), assessed listed (lower risk) or listed (lowest risk). Most complementary medicines are included on the ARTG as listed medicines, whereby the medicine contains only pre-approved ingredients with pre-approved indications, or claims. Even sponsors for listed medicines must maintain a level of evidence on file to support their product claims, which will be evaluated in the event of a TGA audit.
Registered complementary medicines require nonclinical, clinical and quality data to be submitted and evaluated by the TGA similar to that of a prescription medicine application. An assessed listed medicine is somewhere between registered and listed medicines in terms of risk. Typically they contain low risk ingredients but have higher risk indications, these products require a pre-market evaluation by the TGA.
Approved complementary medicines from all three categories are included on the ARTG.
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At Mister Wolf Consulting we have extensive experience in the pharmaceutical industry working with prescription medicines, over the counter medicines, and complimentary medicines with varying risk profiles. It can be difficult to determine which pathway is the best to take and the implications of the chosen pathway on future plans for your product. If you would like to discuss your options please contact us at MWC.
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