International collaboration is not a new concept for the Australian medicines regulator, the Therapeutic Goods Administration. Already, the TGA already works closely with counterparts in Canada, Singapore and Switzerland as part of the ACSS Consortium. It also co-operates with Canada on the regulation of complementary medicine ingredients. This experience should give the TGA the opportunity to gain more momentum to go further.
A stronger regulatory focus on international cooperation has followed Prime Minister Tony Abbott’s statement last October, when he said: “If a system, service or product has been approved under a trusted international standard or risk assessment, then our regulators should not impose any additional requirements for approval in Australia, unless it can be demonstrated that there is a good reason to do so…”
Collaboration with international regulators then featured heavily in a discussion paper released in the following month as part of the government’s independent expert review of regulations governing medicine and medical devices, which included a specific chapter on complementary medicines.
A review of this magnitude for the Australian complementary medicines sector has been described as a “once-in-a-generation opportunity”.
Possibilities on the horizon include the removal of regulatory duplication; streamlining of access to new ingredients; a transparent, streamlined registration pathway for complementary medicines; and regulatory protection mechanisms to incentivise innovation in listed medicine ingredients.
The review raises important dialogue and questions for those in the industry, such as the criteria to determine “trusted overseas regulator”, how to deal with conflicting overseas evaluation reports, and how these evaluations or decisions would be put to use in practice.
Importantly, it can also consider the aspects of safety, quality and efficacy that need to be considered in Australia.
The challenge in front of the review panel and government for the complementary medicines sector will be around striking a balance between pre- and post-market activities for low risk listed medicines that reduce red tape and uphold consumer safety.
More broadly, Australia is seeing a streamlined approach to international standards setting. Earlier this year, Standards Australia, announced its intention to streamline the adoption of international standards.
It its statement, the country’s peak non-government standards body said it would accept and assess proposals for identical direct text adoptions of international standards at any time throughout the year.
The move comes at a time when the federal government has announced greater focus on the international harmonisation of standards and regulatory approval systems.
This opportunity not only presents itself by looking at greater adoption and harmonisation of international standards, but also allows for Australia to have a bigger hand in their development.
Conversations in these areas are already taking place at ISO level.
Thinking globally, Southeast Asia is heading for enormous economic change with its 10-nation Asean single market, and after a decade of planning, the end of 2015 will see member states harmonised under one legal framework.
The supplements sector is one of 12 key priorities of the single market, and it will be included in plans to harmonise safety standards, health claims substantiation and upper levels for vitamins and minerals.
Likewise, removal of over-regulation will help the Australian complementary medicines industry be seen as innovative, competitive and able to meet growing consumer demands.
Now the direction international regulatory convergence will take in Australia depends on the government’s response to recommendations by the expert review panel.
The report for complementary medicines and advertising it expected to be submitted to Government by June 30.
- Emma Burchell is head of regulatory affairs for Complementary Medicines Australia