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The Therapeutic Goods Administration (TGA)The TGA was established in 1990 to safeguard and enhance the health of the Australian Community through effective and timely regulation of therapeutic goods
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About the TGA• A division of the Department of
Health & Ageing
• 630 staff including scientists, toxicologists, technicians, medical officers and pharmacists
• Budget approximately A$120m per annum
• Full cost recovery from industry fees and charges
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Implementing the ICH guidelines• TGA formally adopts European Union
guidelines including those developed by ICH
• For a full list of EU guidelines adopted by TGA see
http://www.tga.gov.au/industry/pm-euguidelines.htm
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Prescription medicines business process improvements
Implemented November 2010
Applicant actions
TGA actions
Pre-submissionplanning form
Dossiersubmission
1st roundevaluation
Informationrequest
2st roundevaluation
Expertadvice
Streamlined submission process
Summaryapplicationinformation
All informationprovided?
No= end
Yes=plan resources
Notify applicant
All informationprovided?
No= end
Yes=proceed to evaluation
Notify applicant
Finalisesubmissiondossier
Evaluation
Prepare information
Respond within 30 or 60 days
Identify additionalinformation needed
Send information request
Assess information
Send evaluation report
Can respond to issues in report max 6 pages
Seek advice from expert committee
Approve or reject
Appeal option available
Decision
Early findings
Old process
New process
NCE Generics
457 427
339 238
Time shown as number of calendar days
Articulating TGA’s regulatory approach
Released 31 May 2012
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TGA regulatory framework
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TGA regulatory framework
Reviewing medicines labels requirements
Released 31 May 2012
http://tga.gov.au/about/tga-regulatory-framework.htm
Key issues• active ingredient prominence
• blister strip labelling
• dispensing sticker space requirements
• standardised format of information
• look alike sound alike names and look alike packaging
• pack insert requirements
• small container labels
• trade name extension
Australia-New Zealand Therapeutic Goods Authority
Announced 20 June 2011
http://www.tga.gov.au/about/international-anztpa.htm
Moving toward ANZTPAA 3 staged approach over a period of up to 5 years.
TGA and Medsafe have commenced a program of work-sharing and increased joint operations.
Building on this, a single entry point for industry will be established and a common trans-Tasman regulatory framework will be agreed.
As business operations become increasingly integrated and a following a review of progress, the single regulator will be established.
By 30 June 2012, the public in Australia and New Zealand will be able to search a data base with information on adverse reactions to medicines.
Develop a common recalls portal for therapeutic products.
Develop a common early warning system.
Review and reform of the business process for the evaluation of over the counter medicines.
Develop an integrated capability to conduct GMP audits by early 2013.
Deliverables for next 12 months
Questions
