7. At this time the The sponsor states: This is not entirely ‘The sponsor’s proposed differences between the PI satisfactory. application of routine and the SmPC are minor and Consequently it is risk minimisation have no impact on the level recommended that activities would of safety profile as described the ASA should appear to be in the RMP and ASA. include a risk reasonable and Therefore no change has minimisation therefore generally been made to the ASA.’ activities table, acceptable. which compares the Nevertheless, the ASA actual content and may need to be revised wording of the if additional ongoing current EU SmPC safety concerns are and the proposed included. Furthermore Australian PI & CMI as per the Risk for all of the Management Plan specified ongoing (RMP) Questions and safety concerns and Answers (Version 1.3, missing October 2012) as found information. This on the TGA website, table should these guidelines state: identify and provide ASA should reasons for any ‘The identify any differences observed between the EU-RMP differences and the local particularly where implementation of risk it appears the EU management activities, SmPC is more for example: any restrictive. The TGA differences between the can then validate risk minimisation the sponsor’s activities undertaken assertion that there as reflected in the are no material content of the EU differences between Summary of Product the routine risk Characteristics (SmPC) minimisation and the proposed activities Australian Product undertaken in Information (PI), and Europe compared to Australia. An the reasons for the difference. This will adequately revised allow the TGA to assess ASA should be submitted for the appropriateness of the proposed RMP in review before this the Australian application is environment.’ approved. Consequently the sponsor should identify and provide reasons for any differences between the risk minimisation activities undertaken as reflected in the content of the EU
7. At this time the sponsor’s proposed application of routine risk minimisation activities would appear to be reasonable and therefore generally acceptable. Nevertheless, the ASA may need to be revised if additional ongoing safety concerns are included. Furthermore as per the Risk Management Plan (RMP) Questions and Answers (Version 1.3, October 2012) as found on the TGA website, these guidelines state: ‘The ASA should identify any differences between the EU-RMP and the local implementation of risk management activities, for example: any differences between the risk minimisation activities undertaken as reflected in the content of the EU Summary of Product Characteristics (SmPC) and the proposed Australian Product Information (PI), and the reasons for the difference. This will allow the TGA to assess the appropriateness of the proposed RMP in the Australian environment.’ Consequently the sponsor should identify and provide reasons for any differences between the risk minimisation activities undertaken as reflected in the content of the EU The sponsor states: ‘The differences between the PI and the SmPC are minor and have no impact on the level of safety profile as described in the RMP and ASA. Therefore no change has been made to the ASA.’ This is not entirely satisfactory. Consequently it is recommended that the ASA should include a risk minimisation activities table, which compares the actual content and wording of the current EU SmPC and the proposed Australian PI & CMI for all of the specified ongoing safety concerns and missing information. This table should identify and provide reasons for any observed differences particularly where it appears the EU SmPC is more restrictive. The TGA can then validate the sponsor’s assertion that there are no material differences between the routine risk minimisation activities undertaken in Europe compared to Australia. An adequately revised ASA should be submitted for review before this application is approved.
auspar-tafluprost-timolol-150728.docx