The Therapeutic Goods Administration has released its annual business plan update, revealing a focus on major regulatory reform and a continued international perspective for 2019-20.
The updated plan sets out the organisation’s product regulation, regulatory reform, international engagement and regulatory compliance agenda along with an overview of key activities and commitments intended to achieve the outcomes planned for delivery in 2019-20.
Planned major regulatory reform activities include those covering prescription medicine, complementary and over-the-counter medicine, medical device, scheduling and post-market monitoring.
Of special interest to pharmacists, the TGA says, are the planned activities related to prescription medicine. These include:
- Enhancing business processes and IT systems to support prescription medicines process, reforms and future electronic submissions.
- Finalising and supporting the adoption of the revised Consumer Medicine Information template by industry.
- Implementing further improvements to business processes for minor variations to prescription medicines, including recognition of additional types of variations that can be ‘notified’ to the TGA.
Activities planned for complementary and over-the-counter medicine reforms include:
- Consulting with stakeholders to develop and implement a mechanism to make it clear which products, including sports supplements, are considered therapeutic goods for the purposes of the Therapeutic Goods Act 1989.
- Use of evaluation reports from comparable overseas regulators for evaluation of registered complementary medicines, assessed listed medicines and listed medicine ingredients.
- Developing new approval pathways for sunscreen ingredients and excipients.
Under the scheduling reform section, the Poisons Standard will be receiving attention, with the TGA planning activities to implement a framework for the use of Appendix M of the Standard to allow additional conditions on medicines that are down-scheduled from prescription only to pharmacist only medicines.
As part of its responsibility for core regulatory activity, the TGA plans activity to monitor and enforce compliance of therapeutic goods, including:
- Reducing low level non-compliance through education and guidance using proactive communication strategies.
- Monitoring the market for signals of potential non-compliance, through complaints, referrals and intelligence activities, and carrying out investigations against a risk based compliance framework, utilising appropriate education and enforcement approaches to address and deter non-compliance.
- Developing compliance plans to address compliance priorities identified during the year through monitoring, data analysis and intelligence activities.
- Continuing to collaborate with state, territory, federal and international partners on matters of compliance and intelligence.
The TGA’s ‘International Engagement Strategy 2016-2020’ initially set out three main goals for international work: to contribute to public health and safety through regulation, to work with others to improve regulatory systems, and to participate in work sharing and convergence activities.
While these all remain core to the 2019-20 plan, this year the TGA has included an activity to “participate in programs to develop enhanced collaboration frameworks with comparable overseas counterparts and promote the use of aligned regulatory systems and processes to reduce unnecessary duplication of effort across regulators”.
The TGA says this international objective shows a healthy alignment with the aims of the International Pharmaceutical Federation (FIP), introduced at the organisation’s Congress in Abu Dhabi recently by FIP President Dominique Jordan.
Mr Jordon said decreasing the gaps in pharmaceutical science, practice and education between different regions of the world was among the aims of the new FIP strategy.
The TGA business plan is updated annually and is a central part of its activity planning and performance monitoring framework. The full 2019-20 plan can be viewed online here.
