The presentation was given by the TGA at the 2014 ARCS Scientific Congress, and covers proposed changes and possible impacts to risk management plans

1. Risk Management Plans – proposed changes
Dr Jane Cook
Head of Office, Office of Product Review, Monitoring & Compliance Group, TGA
ARCS Scientific Congress 2014
11 September 2014

2. Overview
• Why have RMPs been required
• RMP statistics
• Current requirements
• Proposed changes
• Potential Impact of changes
• Consultation
• Other initiatives
• Questions
Risk Management Plans – proposed changes 1

3. Why have RMPs been required?
• Limited information from clinical trials (CTs)
• Not always representative of real world usage due to inclusion and exclusion criteria in CTs
• Potential risks identified but not fully characterised during CTs
• Missing information in certain population groups – children, pregnant women and the elderly
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4. What is a risk management plan for?
Outlines the risk management system for a medicine once it is available for use in Australia.
Comprises:
• Known safety profile
• Identified and potential safety concerns and where appropriate how they will be mitigated
• Missing safety information where this is known or can be predicted and how this will be managed
Focuses on:
• Monitoring – Pharmacovigilance Plan
• Minimising risks associated with the use of the product – Risk Minimisation Activities
Provides:
• Coverage of the life cycle of the product
• Assurance that all risks related to the use of a medicine have been considered and acted upon
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5. RMPs to date
• Requirement commenced 1 April 2009
• RMPs for “high risk” medicines now required for more than 5 years
• RMPs evaluated:
Year Number of RMPs evaluated
2009 8
2010 70
2011 50
2012 82
2013 131
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6. RMPs currently required for
• A New Chemical Entity
• Generic medicines where innovator product has additional risk minimisation activities
• Paediatric use
• Extension of indication
• Significant change to dosage form or route of administration
Follows EU guidelines
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7. Proposal 1
Submit EU RMP (where this exists) and Australian Specific Annex (ASA)
• Advantages:
– Allows a sponsor to use a current EU RMP without alteration
– Provides a simple way of providing information to TGA as to proposed activities to be undertaken in the EU
and why they are or are not being undertaken in Australia (e.g. patient registries and post-marketing
studies)
– Assists sponsors in not having to produce and manage multiple versions of the same RMP for different
regulators
• Disadvantages:
– May involve additional work for sponsor
– Not all sponsors will have EU RMP
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8. Australian specific annex
Purpose:
• Provides specific information about risk in the Australian population, including the indigenous population
• Provides information as to the relevance of proposed pharmacovigilance and risk minimisation activities to
the Australian population
• Identifies and explains any differences between what proposed in the EU and Australia for these activities
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9. Proposal 2
• The TGA will undertake a risk based assessment of the Pre-submission Planning Form (PPF) as to whether
an RMP with an ASA needs to be submitted with the application
• Where the application for the medicine is assessed to not demonstrate a new or increased level of risk the
sponsor will not be required to submit an RMP
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10. Submissions that may not require an RMP & ASA
• Change in population does not differ substantially from existing treatment group
• Change in population does not indicate a new safety risk or change in safety profile
• Change in form, dose or route does not result in an increase in risk or significant change in safety profile
• Combination products with a long history of use and commonly used together
Current circumstances where an RMP is not required will continue, i.e. generic medicines, low risk biological
products
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11. Submissions that would always require an RMP & ASA
• New Chemical Entities
• Paediatric indications
• Biosimilars
• Higher risk (Class 3 and 4) biologicals
• Generic medicines where innovator product has additional risk minimisation activities
• Vaccines
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12. Potential impact
• Analysis of of RMPs received from January to April 2014 showed that approximately 25% fewer RMPs would
have been required
• Reduction in requirement to provide PSURs to the TGA
• Routine pharmacovigilance requirements maintained
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13. Consultation
• Liaison with RMP Expert Working Group of ARCS
• Industry bodies – Medicine Australia and Generic Medicines Industry of Australia
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14. Other initiatives
• Australian Specific Annex Template
• New RMP Questions and Answers
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15. 14
Questions?
Risk Management Plans – proposed changes