This presentation provided an understanding of the Australian pharmacovigilance inspection program

1. An Australian Pharmacovigilance Inspection Program
Pilot Program
Sarah May
Pharmacist
Signal Investigation (Medicines) Unit
Post-market Surveillance Branch
Association of Regulatory and Clinical Scientists (ARCS) Workshop
12 March 2015

2. Overview
• Background
• PV Inspections
• The Pilot
• How to volunteer
• Next steps
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Program
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3. Background
• International pharmacovigilance inspection programs:
– FDA – Postmarketing adverse drug experiences inspections (1997)
– EMA – Statutory PV inspections and CHMP directed – all EU member states
– MHRA – Statutory PV inspection program (2003)
• Australian sponsors are required to meet specific reporting obligations in relation
to pharmacovigilance as set out in the Therapeutic Goods Act (1989),
Therapeutic Goods Regulations (1990) and the Australian requirements and
recommendations for pharmacovigilance responsibilities of sponsors of
medicines (June 2014)
• TGA wants to ensure companies have adequate Pv systems in place to ensure
medications available to Australian consumers are safe and effective
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Program
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4. PV Inspections- the process
• Early days…
• Mixture of interviews and document review
• Communication of findings: Inspection report
• Company to undertake corrective and preventative actions
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5. What will be inspected
• Collection and collation of ADR reports
• Reporting of ADRs to TGA - complete, accurate and timely
• Ongoing monitoring and identification/reporting of significant safety issues
• Quality systems - SOPs and training
• Development and submission of PSURs
• Adherence to RMP commitments
• Alignment of PI/CMI with current information
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6. First Step- Pilot Program
• Requesting volunteer pharmaceutical companies
• Complete an Australian Pharmacovigilance System Summary
• Up to 10 companies will be selected
• Inspections will be planned and undertaken
• Inspection reports completed
• Participating companies will be asked to provide feedback and complete a
questionnaire
• Pilot assessment and report
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7. Why volunteer
• Quality improvement practices
• Improve visibility of pharmacovigilance within companies
• Free!
• Delayed re-inspection subject to findings
• Feedback and help tailor the program to Australian specific requirements
Further information:
• Email: sarah.may@tga.gov.au
• Ph: 02 6232 8753
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8. Next Steps
• Analysis of the pilot:
– Is an inspection program relevant and suitable for
Australia?
– Scope of the program
– Review of inspection processes
• Development of a National Pharmacovigilance
Inspection Program:
– Development of internal processes and training of staff
– Scheduling of inspections
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Program
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9. Summary
• Background
• PV Inspections
• The Pilot
• How to volunteer
• Next steps
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Program
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10. Questions
“It is not the answer that enlightens, but the question.” – Eugene Ionesco
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Program
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