tga: the current regulatory reform agenda - asmi.com.au skerritt final.pdf · the therapeutic goods...
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ASMI 2012 Conference: 13 November 2012
Future proofing the consumer healthcare industry
Dr John Skerritt, National Manager
TGA:
the current regulatory reform agenda
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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
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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
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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
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Released by Parliamentary
Secretary King in December
2011 in response to recent
reviews of TGA
Implementation Plan released
July 2012
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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
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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
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TGA reforms of
complementary medicines In response to:
- Transparency review
- Informal working group deliberations
- Auditor-General’s report
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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
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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
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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
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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
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TGA reforms:
OTC medicines
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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
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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
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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
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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