identified or explained. Furthermore to be consistent references to the RMP’ in Section 3.8.1 ‘global of the ASA should be amended to refer to the Consequently the sponsor should revise the ASA accordingly and provide an updated version to the TGA for review. 2. Safety considerations may The sponsor acknowledged this The clinical evaluator be raised by the clinical recommendation. has suggested wording evaluator and/or the for the indication which Clinical Evaluation Report. It differs from that stated is important to ensure that in the updated ASA. the information provided in Consequently the response to these includes a sponsor should revise consideration of the the ASA accordingly if relevance for the RMP, and required, preferably any specific information before this application is needed to address this issue approved. in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. 3. Even though uveitis and The sponsor acknowledged this This proposal is only scleritis are no longer recommendation and has added the acceptable if the sponsor classified as important following sentence to Section 2.1 of the provides an assurance potential risks, the sponsor ASA: pharmacovigilance is that future Periodic ‘Routine should amend the ASA to conducted for all adverse reactions in Safety Update Reports state that routine addition to the risks identified in the (PSURs) will specifically pharmacovigilance and RMP.’ report on the safety routine risk minimisation concerns: uveitis and are nevertheless applied to scleritis. these safety concerns. 4. The studies referenced in The sponsor acknowledged this Attachment I –Additional the pharmacovigilance plan recommendation and revised the ASA pharmacovigilance will generate safety data accordingly. activities and estimated that will simply support the Australian submission safety profile of the dates of the updated ASA medicine, while others will does not appear to be generate data that will consistent with or as provoke applications to comprehensive as Table amend the Australian 85: and Planned ‘Ongoing registration details. It is Additional PhV acknowledged that the Studies/Activities in the sponsor’s correspondence Pharmacovigilance Plan’ dated August 2013 states of the updated EU-RMP. that all paediatric study Consequently the reports and updates that are sponsor should correct submitted to the EU will this oversight and revise also be submitted to the ASA preferably Australia with the same before this application is timelines. Nevertheless to approved.
identified or explained. Furthermore to be consistent references to the ‘global RMP’ in Section 3.8.1 of the ASA should be amended to refer to the Consequently the sponsor should revise the ASA accordingly and provide an updated version to the TGA for review. 2. Safety considerations may be raised by the clinical evaluator and/or the Clinical Evaluation Report. It is important to ensure that the information provided in response to these includes a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. The sponsor acknowledged this recommendation. The clinical evaluator has suggested wording for the indication which differs from that stated in the updated ASA. Consequently the sponsor should revise the ASA accordingly if required, preferably before this application is approved. 3. Even though uveitis and scleritis are no longer classified as important potential risks, the sponsor should amend the ASA to state that routine pharmacovigilance and routine risk minimisation are nevertheless applied to these safety concerns. The sponsor acknowledged this recommendation and has added the following sentence to Section 2.1 of the ASA: ‘Routine pharmacovigilance is conducted for all adverse reactions in addition to the risks identified in the RMP.’ This proposal is only acceptable if the sponsor provides an assurance that future Periodic Safety Update Reports (PSURs) will specifically report on the safety concerns: uveitis and scleritis. 4. The studies referenced in the pharmacovigilance plan will generate safety data that will simply support the safety profile of the medicine, while others will generate data that will provoke applications to amend the Australian registration details. It is acknowledged that the sponsor’s correspondence dated August 2013 states that all paediatric study reports and updates that are submitted to the EU will also be submitted to Australia with the same timelines. Nevertheless to The sponsor acknowledged this recommendation and revised the ASA accordingly. Attachment I –Additional pharmacovigilance activities and estimated Australian submission dates of the updated ASA does not appear to be consistent with or as comprehensive as Table 85: ‘Ongoing and Planned Additional PhV Studies/Activities in the Pharmacovigilance Plan’ of the updated EU-RMP. Consequently the sponsor should correct this oversight and revise the ASA preferably before this application is approved.
auspar-etanercept-150923.docx