while others will generate Planned Studies in the 2013 and Q4 2013 data that will provoke Post-Authorisation respectively. Consequently applications to amend the Pharmacovigilance it is reiterated that the Australian registration Development Plan. This anticipated dates for the details. To this end it is section does not include submission in Australia of suggested that the sponsor anticipated dates for their studies referenced in the should provide an submission in Australia, pharmacovigilance plan attachment to the ASA but rather refers to the should be included in this setting out all the RMP table for estimated section of a revised ASA forthcoming studies and timelines for data before this application is the anticipated dates for availability. The sponsor approved. their submission in states that following Australia. availability of data from these studies, the results will be assessed and if deemed necessary, the company Core Data Sheet (CDS) will be updated. Any relevant safety updates to the company CDS, will result in applications to amend the PI. The submission In the revised ASA This is acceptable. ‘RMP history table’ of the ASA provided, the ‘Change should state that the history of RMPs submitted guided questionnaires to TGA’ tables notes that erroneously associated Guided Questionnaires with the important erroneously associated missing information: with the Important during pregnancy’ Missing information ‘Effects and Impairment’ during pregnancy’ ‘Hepatic ‘Effects have now been removed in and Impairment’ ‘Hepatic the ASA Version: 3.0. in ASA v1.0 have been removed from the ASA. The sponsor should A draft protocol for the This is acceptable. provide an update on the pJIA paediatric patient status of the unnamed registry is now available paediatric patient registry and has been provided in and provide an assurance Annex 5 of the updated that if it is still not yet ASA. The protocol has initiated at least a draft been submitted to EMA protocol will be submitted and FDA for review and to the TGA for review once therefore is considered a it becomes available. draft.
while others will generate data that will provoke applications to amend the Australian registration details. To this end it is suggested that the sponsor should provide an attachment to the ASA setting out all the forthcoming studies and the anticipated dates for their submission in Australia. Planned Studies in the Post-Authorisation Pharmacovigilance Development Plan. This section does not include anticipated dates for their submission in Australia, but rather refers to the table for estimated timelines for data availability. The sponsor states that following availability of data from these studies, the results will be assessed and if deemed necessary, the company Core Data Sheet (CDS) will be updated. Any relevant safety updates to the company CDS, will result in applications to amend the PI. 2013 and Q4 2013 respectively. Consequently it is reiterated that the anticipated dates for the submission in Australia of studies referenced in the pharmacovigilance plan should be included in this section of a revised ASA before this application is approved. The ‘RMP submission history table’ of the ASA should state that the guided questionnaires erroneously associated with the important missing information: ‘Effects during pregnancy’ and ‘Hepatic Impairment’ have now been removed in the ASA Version: 3.0. In the revised ASA provided, the ‘Change history of RMPs submitted to TGA’ tables notes that Guided Questionnaires erroneously associated with the Important Missing information ‘Effects during pregnancy’ and ‘Hepatic Impairment’ in ASA v1.0 have been removed from the ASA. This is acceptable. The sponsor should provide an update on the status of the unnamed paediatric patient registry and provide an assurance that if it is still not yet initiated at least a draft protocol will be submitted to the TGA for review once it becomes available. A draft protocol for the pJIA paediatric patient registry is now available and has been provided in Annex 5 of the updated ASA. The protocol has been submitted to EMA and FDA for review and therefore is considered a draft. This is acceptable. RMP
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