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The presentation was given by the TGA at the 2014 ARCS Scientific Congress, and covers communication between the TGA and Industry, as well as future directions
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Prescription medicine registration process
Industry and TGA expectations
Jenny Burnett
Director, Business Reform, Office of Medicines Authorisation,Market Authorisation Group, TGA
ARCS Scientific Congress 2014
10 September 2014
2Prescription medicine registration process
Topics for discussion
1. Communication between TGA and industry on the registration of prescription medicines
2. Common issues with applications
3. Future directions
3Prescription medicine registration process
Communication between TGA and industry - slide 1• The role of the case manager
– Main point of contact– Assistance versus consultancy
• Types of requests– Progress reports – ‘Special requests’– Appropriate use of TGA guidance documentation– Good communication = clarity + brevity
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Communication between TGA and industry - slide 2• ‘Streamlined submissions’ inbox
– Inclusion of submission number in title– Why send a general enquiry here?
• TGA’s customer services standards
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Common issues with applications - slide 1• Is the application ‘effective’?
– Legislative requirements - section 23 Instruments– Resources assessment– Accepted for evaluation– Some statistics….
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Review of applications
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Common issues with applications - slide 2• Common reasons for PPFs to be determined ‘not effective’
– GMP clearances: recent change to requirement– Missing data
• Common reasons why applications are determined ‘not effective’– No methodology/method validation (micro, endotox)– Mod 3 missing data: stability– Mod 3 impurity limits– Mod 4/5 missing studies or references
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Future directions
1. Pressure points within the process– Time between MS7 and MS8– Role of the PPF and need for module 2 summaries
Balancing flexibility with predictability
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2. International work-sharing– First step is confidence building– Health Canada and generic medicines– New chemical entities and orphan medicines
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3. eCTD– Advantages of an electronic system
Hard copy of dossier Internal paper based processes
– Considerations needed What is an ‘effective application’?
