TB screening brochure TB screening checklist Publications on specific safety topics In regard to routine risk minimisation the draft Product Information and Consumer Medicine Information were considered to be satisfactory. The following table (Table 2) summarises the OPR’s evaluation of the RMP, the sponsor’s responses to issues raised by the OPR and the second round OPR evaluation of the sponsor’s responses. Table 2. Reconciliation of issues outlined in the RMP report. Continued across 2 pages. Recommendation in RMP evaluation Sponsor’s response OPR evaluator’s comment report Safety considerations may be The safety profile of This was considered raised by the clinical and adalimumab is well acceptable. evaluators through the established and no safety TGA’s consolidated requests issues requiring further and/or the nonclinical and clinical consideration were raised Evaluation Reports respectively. It in the TGA”s consolidated is important to ensure that the request for information. information provided in response AbbVie has not yet received to these includes consideration of a copy of the clinical the relevance for the Risk evaluation report. Management Plan and any specific information needed to address this issue in the RMP. For any safety considerations so raised, please provide information that is relevant and necessary to address the issue in the RMP. The sponsor should provide The sponsor has provided The current and planned further detail of the education further detail and draft activities as outlined in the program for Australia including versions of the educational sponsor’s response were whether it is already in use, draft materials. acceptable from a RMP education materials and a standpoint. Such detail distribution plan. should be included in the Australian-specific Annex when it is next updated and provided to the TGA. The RMP states that "affiliates are Abbvie is currently This approach was implementing country-specific developing an evaluation considered acceptable. evaluations". The sponsor should tool to assess the Once developed, further provide more detail on the effectiveness of the detail of this assessment Australian specific evaluation of Australian educational should be included in an the effectiveness of the education program. An online survey updated to the risk program. will be conducted by an minimisation section of independent third party the Australian-specific vendor each year for 2 Annex and submitted to years after approval of new the TGA. indications. Participants will be a representative cross section of potential Humira prescribers.
TB screening brochure TB screening checklist Publications on specific safety topics In regard to routine risk minimisation the draft Product Information and Consumer Medicine Information were considered to be satisfactory. The following table (Table 2) summarises the OPR’s evaluation of the RMP, the sponsor’s responses to issues raised by the OPR and the second round OPR evaluation of the sponsor’s responses. Table 2. Reconciliation of issues outlined in the RMP report. Continued across 2 pages. Recommendation in RMP evaluation report Sponsor’s response OPR evaluator’s comment Safety considerations may be raised by the clinical and evaluators through the TGA’s consolidated requests and/or the nonclinical and clinical Evaluation Reports respectively. It is important to ensure that the information provided in response to these includes consideration of the relevance for the Risk Management Plan and any specific information needed to address this issue in the RMP. For any safety considerations so raised, please provide information that is relevant and necessary to address the issue in the RMP. The safety profile of adalimumab is well established and no safety issues requiring further consideration were raised in the TGA”s consolidated request for information. AbbVie has not yet received a copy of the clinical evaluation report. This was considered acceptable. The sponsor should provide further detail of the education program for Australia including whether it is already in use, draft education materials and a distribution plan. The sponsor has provided further detail and draft versions of the educational materials. The current and planned activities as outlined in the sponsor’s response were acceptable from a RMP standpoint. Such detail should be included in the Australian-specific Annex when it is next updated and provided to the TGA. The RMP states that "affiliates are implementing country-specific evaluations". The sponsor should provide more detail on the Australian specific evaluation of the effectiveness of the education program. Abbvie is currently developing an evaluation tool to assess the effectiveness of the Australian educational program. An online survey will be conducted by an independent third party vendor each year for 2 years after approval of new indications. Participants will be a representative cross section of potential Humira prescribers. This approach was considered acceptable. Once developed, further detail of this assessment should be included in an updated to the risk minimisation section of the Australian-specific Annex and submitted to the TGA.
auspar-adalimumab-140122.docx