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Work programme 2017

WC500221614

Results Forecasts 2014

Results Forecasts 2014 2015 2016 2017 criteria at MAA stage Performance indicators Results Targets 2014 2015 2016 2017 Applications evaluated within legal timeframes 100% 100% 99% 100% Average assessment time for new active substances and 200.7 197.2 205 biosimilars Average clock-stop for new active substances and biosimilars 138.4 136.1 180 % of requests granted for accelerated assessment 48% 70% % of MAAs initiated under accelerated assessment that have 43% 70% been completed as accelerated assessment % of initial marketing authorisation applications 82% 63% 80% (orphan/non-orphan/biosimilar) that had received centralised scientific advice Labelling review of the English product information Annexes 97% 90% for new MAAs and line extensions by Day 10 and Day 140 of the evaluation process % of comments on product information submitted during 90% assessment procedure and taken on-board by assessors % of therapeutic guidelines progressed to next step or 70% finalised (vs planned) % of early background summaries drafted and sent to 100% assessment teams (vs planned) % of outcomes/results of workshops on therapeutic objectives published on EMA website 100% Additional objectives and activities In addition to delivering its regular initial-evaluation activities for human medicinal products, the Agency plans to undertake and progress the following additional activities: Medium-term objective MAWP initiative Activity description Timeframe Start End Provide high quality, robust, scientifically sound and consistent scientific assessments of marketing authorisation applications Embedding pharmacovigilance planning in clinical guidelines 3.2-15 Continuously improve the tools (guidance, and databases) available to EMA staff supporting scientific evaluation activities of the committees 3.2-1 Monitor the conduct of pre-submission meetings and continue optimisation towards improved support for the later evaluation 3.2-15 Develop and maintain guidance and other tools (training material, checklist, metrics) Before 2015 After 2017 2015 2017 2016 2017 Work programme 2017 EMA/583016/2016 Page 50/123

Medium-term objective MAWP initiative Activity description Timeframe Start End and improve quality of risk management review and better use of resources embedding pharmacovigilance planning in clinical guidelines, supporting risk management planning and stakeholder interaction Ensure and run highly effective and efficient processes to 3.2-14 Streamline and strengthen the process of input by Quality Working Party and other 2015 After 2017 deliver initial evaluation activities quality of medicines working groups to the relevant parts of assessment report 3.2-1 Optimise and embed in the Agency the 2016 2018 process performance management system with strong customer focus on quality, simplification and regulatory procedural excellence Improve guidance and provide internal and 2016 2107 external trainings to ensure regulatory procedural consistency Establish an internal system of knowledge Q1 2106 2017 sharing with the aim of providing consistent regulatory advice to the NCAs and MAHs Deliver workflow/case management solutions 2017 2019 to reduce the Agency's and Network’s administrative burden and facilitate collaboration using online tools Develop regular interactions with industry, 2015 2017 HTAs and HCPs to promote the operations of the evaluation activities and engage with industry in their optimisation Create a platform for collaboration with NCAs 2017 2018 to understand level of satisfaction and identify improvement opportunities Simplify the handling of generic applications, 2017 2018 to increase the capacity whilst maintaining quality Provide high quality, robust, scientifically sound and 3.3-6 Develop and maintain guidance and other tools (training material, checklist, metrics or Before 2015 After 2017 consistent product information labelling review guide) supporting SmPC review Develop tools for improved oversight of 2017 2018 labelling development during the lifecycle, supporting consistent and evidence-based reviews 3.3-7 Analyse external requests regarding the 2016 2017 contents of approved SmPC and provide consistent response Increase reliance of other 4.3-4 Implement collaborations with FDA on 2016 2018 Work programme 2017 EMA/583016/2016 Page 51/123

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