Blackmores Chairman, Marcus Blackmore AM said, "It is simply not true that Australian Complementary Medicines are not tested for safety and quality. Australia has the most highly regulated complementary medicines in the world. Listed complementary medicines are low-risk products that offer significant health benefits to consumers so it¡¯s important to get the regulatory system right. The TGA has evaluated every product on their register for safety and quality and each product sponsor has a legal responsibility to ensure they hold evidence to support the claims they make"
Dr Wendy Morrow, Executive Director of the Complementary Healthcare Council (CHC) says, "the Australian Complementary Medicines Industry regulations are viewed by most developed countries as the consumer protection benchmark. We are proactively working with the TGA to ensure Australians have access to high quality, safe, effective and readily available complementary medicines"
All complementary medicines (CMs) must be manufactured under the same code of Good Manufacturing Practice as prescription medicines. Listed CMs all contain ingredients permitted by the TGA for use in low risk medicines. Companies must hold evidence to support all indications and claims made for their products. The TGA conducts regular post-marketing surveillance to monitor compliance. Registered CMs are assessed individually for quality, safety and efficacy.
The CHF is appealing to people to learn more about the complementary health products they are taking but in fact consumers are already well educated, with the 2011 Complementary Medicines Industry Audit showing 74% of Australian consumers use CMs regularly, and 75% are able to name the exact CM they take and why.
Mr Blackmore said, "Blackmores has a strong commitment to providing our customers with quality, safe and efficacious products. We ensure that our products consistently meet or exceed the expectations of our customers as well as comply with regulatory requirements. Blackmores strongly supports the industry regulations and has robust processes in place to maintain compliance with the regulations"
Blackmores' compliance processes include:
- Extensive research process to expertly assess evidence to support our claims
- Blackmores products are made to exacting pharmaceutical manufacturing standard requirements under the international PIC/s (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) standards of Good Manufacturing Practice.
- Over 3000 stability tests performed each year
- Blackmores contributes to industry consultation on regulatory improvement
- All Blackmores suppliers are thoroughly audited
- All our manufacturers are TGA accredited and undergo regular TGA audits as well as Blackmores audits that focus specifically on our products
- In process checks are performed every 20 minutes on our packaging lines
- Annual product quality reviews
- Blackmores adheres to a stringent internal and external approval process for advertising
- All raw materials used are assessed and quality approved.