Following their success in the Canadian and US markets, many companies seek to sell their products in foreign markets, of which Australia can be an attractive choice. The lack of language barrier with English-speaking representatives simplifies communication with the Australian regulators (the Therapeutic Goods Administration, TGA), and the country’s robust $3.5 billion/year supplement industry is expected to grow to $4.6 billion in 2017-2018. It is estimated that more than two thirds of Australians use complementary medicines regularly. If sale in Australia is a goal for your company, we want to draw your attention to a difference between Australian and North American regulatory barriers that can significantly delay your launch date.
In Australia, there is a greater scrutiny upfront on the manufacturing process, rather than a paper-based screening process. The TGA regulates the manufacture of supplements and natural medicines (called “complementary medicines” in Australia) in a similar fashion to the way drugs/nhp’s are regulated in Canada., Products manufactured to Canadian natural health product (NHP) standards or United States dietary supplement standards are not immediately recognized as being of suitable quality for sale in Australia. To the contrary, companies wanting to sell their Canadian or US-manufactured products in Australia must demonstrate that the manufacturing facilities employ good manufacturing practices (GMP) equivalent to those required for drugs.
Australia’s rigorous manufacturing standard for supplements stems from perhaps the world’s biggest recall of medicinal products, which occurred in Australia in 2003. In this year, the TGA audited Australia’s then largest contract manufacturer, Pan Pharmaceuticals Ltd., and found them in dramatic breach of GMP. Among the failures reported by the TGA were the substitution of ingredients, manipulation of finished product test results, poor hygiene and inadequate cleaning of the facility, incorrectly calibrated equipment, and deficient documentation. As a result of the audit failure, the TGA suspended Pan Pharmaceuticals’ manufacturing license, and ordered a recall of all manufactured products. Over 1600 branded products were affected at the retail level, and an estimated 50% of the medicine supply on the Australian market was recalled. Some of the recalled products were manufactured for export, so over 20 countries outside Australia were also affected by the recall.
As a contract manufacturer, Pan Pharmaceuticals manufactured products not only for their own brand, but also for other companies, and the TGA’s closure of Pan Pharmaceuticals resulted in the loss of hundreds of jobs and tens of millions of dollars by shareholders and retailers; 87 people became ill and 19 were hospitalized from consuming contaminated products. Pan Pharmaceuticals itself, then a $350 million company, was immediately dissolved. (Interestingly, the owner of Pan Pharmaceuticals, Jim Selim, later won a civil suit against the Australian government about the way the TGA handled the recall, and Selim was awarded $55 million, a cost ultimately footed by Australian taxpayers.)
The Pan Pharmaceuticals recall triggered immediate changes in the way the Australian authorities regulated supplements and medicines. Penalties for non-compliance (including not following GMP or making false attestations on applications) were increased; new offences for falsifying test results or using a manufacturing site not approved by the TGA were introduced; and additional responsibilities regarding adverse event reporting and recall/record-keeping procedures were made mandatory for manufacturers and brand owners.
So what does this mean for a Canadian or US-based company wanting to export their natural health product or dietary supplement to Australia? The first hurdle experienced by many North American countries is the accreditation of their manufacturing facilities. Accreding a manufacturing facility is a requirement for all products for sale in Australia, regardless of the facility’s location (including the US and Canada).
If you have flexibility with where your products are manufactured and you’re interested in selling in Australia, you should look for a contract manufacturer who has a GMP Clearance number from the TGA. If you need to use a specific manufacturing facility that isn’t yet accredited by the TGA, you should start the process of applying for GMP Clearance as soon as possible, since approval of foreign facilities by the TGA can be a lengthy process.
NHP Consulting has expertise in the Australian market, and can provide a GMP clearance number for your manufacturing facilities. The Australian market is growing – and is a strategic launchpad for the Asia Pacific market – but expert care is required to avoid delays. Learn more by reading up on the requirements here.