TGA: the current regulatory reform agenda

Transcription

1 TGA: the current regulatory reform agenda ASMI 2012 Conference: 13 November 2012 Future proofing the consumer healthcare industry Dr John Skerritt, National Manager

2 The Therapeutic Goods Administration Regulates therapeutic goods including prescription, over the counter and complementary medicines, medical devices, blood and blood products Evaluates therapeutic goods before they are marketed and monitors products once they are on the market Assesses the suitability of medicines and medical devices for export Focuses on safety, efficacy and quality Works closely with consumers, health professionals, industry and international counterparts

3 Why does TGA regulate OTC and complementary medicines? Recognition of the role of these medicines for treatment of self-limiting conditions To meet consumer expectations that therapeutic products are regulated to ensure standards of quality and safety are met Recognition that some OTC medicines can have significant adverse effects if used inappropriately To ensure that indications and claims on labels are evidence-based To set consistent labelling requirements

4 TGA s major priorities in 2012/13 Business as usual - regulation of therapeutic goods for safety, efficacy and quality Delivery of reforms outlined in the Blueprint and communicate objectives and timetable Stronger stakeholder engagement Regulatory reform Establishment of ANZTPA Integration with wider health policy

5 Released by Parliamentary Secretary King in December 2011 in response to recent reviews of TGA Implementation Plan released July 2012

6 Major Blueprint work areas for 2012/13 Communication and stakeholder engagement Advertising reforms consider pre-approvals approach, single entry point enforce sanctions for breaches Complementary medicines levels of evidence required, coded indications risk-based approach to post-market reviews Medical devices TGA Governance and management Accelerate organisational change

7 ANZTPA joint agency to commence in 2016 Database for Adverse Events Notification launched 1 August 2012 Other Business to Business projects: common recalls portal for therapeutic goods and common early warning system review and reform business process for evaluation of over-the-counter medicines sharing of Good Manufacturing Practice (GMP) reports Development of a single entry point for industry Establishment of a common regulatory framework Development of new rules for how ANZTPA will be governed and operate Natural Products in NZ will be outside the scheme Major effort in policy and legislative development

8 TGA reforms of complementary medicines In response to: - Transparency review - Informal working group deliberations - Auditor-General s report

9 Planned actions: consultation and communication Define, adopt and publish consultation principles to guide reform Develop and implement a comprehensive communication strategy Improve availability of complementary medicines information from TGA provide user-friendly information to consumers about the difference between listed and registered medicines Timely completion of key guidance materials Improve information available on advertising regulation more efficient processing of advertising complaints publication of decisions on advertising complaints and investigations

10 Planned actions: regulation Improving the integrity of the listing system limit use of inappropriate claims coded indications eliminate free text in Electronic Listing Facility Improve labelling and packaging in consultation with industry Apply, publicise and enforce penalties for advertising breaches Enhance sanctions for repeated non-compliance

11 Listable indications proposed approach Should be described as a nominated effect on a target biological process or clinical condition Can use either scientific indications or traditional indications Sponsors required to hold evidence for indications scientific indications efficacy based traditional indications use in a particular paradigm Health maintenance/ enhancement or management of non-serious self limiting conditions Listed medicines must only contain ingredients approved by TGA

12 Greater transparency of post-market review and compliance monitoring TGA to make information available on compliance review selection, processes and outcomes Enhancing post-market monitoring focus post-market monitoring towards problem areas improve post-market review data to inform selection of reviews Develop and implement standard processes for investigating advertising breaches for complementary medicines establish timeframes for the completion of investigations identify significant trends in non-compliance

13 TGA reforms: OTC medicines

14 OTC Business process redesign Deliver more efficient and cost-effective OTC medicine evaluation Provide greater transparency and predictability of the regulatory process Ensure an appropriate benefit/risk model is applied Harmonise OTC medicine evaluation processes in Australia and NZ Consultation paper released 17 September 2012 Putting additional resources into reducing application backlog

15 Proposed approach Establish risk categories for OTC medicines applications Define application requirements, business processes, target times and data requirements for each category Require applications to be in the common technical document (CTD) format Develop OTC medicine monographs for previously-approved and well-characterised active ingredients

16 Advertising Therapeutic Goods to consumers Public consultation on improvements to arrangements for advertising conducted in 2010 Four areas were identified for further review: pre-approval of advertisements role? Include pay TV and medical devices? complaints handling arrangements a single entry point within TGA for receiving all advertising complaints? penalties and sanctions available for advertising breaches Information paper published in May 2012 Further consultation on policy options currently underway

17 In conclusion TGA recognises the importance of the OTC medicines industry and the central role of informed self medication in managing demands on the healthcare system Regulation relative to the level of risk is critical TGA commits to improved communication with industry and consumers, including consulting on proposed reforms Although complementary and OTC medicines are lower in risk than prescription medicines, inappropriate promotion and use can: stop chronically ill people from seeking necessary treatment lead to serious side effects for some products, and affect TGA s reputation as a regulator