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Work programme 2017

WC500221614

Public health needs and

Public health needs and priorities Ensure needs of specific populations are met, including elderly, children, patients with rare diseases and others 1.1-4 Contribute to Global Action Against Dementia (GAAD) 2015 2017 High - implementation of the actions in the GAAD - increased number of new medicines for dementia 1.1-5 Implement the geriatrics strategy 2011 2019 Medium - level of strategy implementation - proportion of actions implemented - deliverables completed (guidelines, pilot outcomes, GVP module) 1.1-6 Support innovation, early dialogue and research for paediatric medicines 2007 2019 Medium - increased support to early interaction with developers of paediatric medicines (number of early interactions, expanded common commentaries with the FDA, other pre-submission interactions) - number of scientific workshops / expert meetings to support innovation in paediatric medicines 1.1-7 Scientific and regulatory contribution enhancing drug safety in pregnancy 2015 2017 High - delivery of the GVP module on ”special populations(III): pregnant and breastfeeding women” 1.1-8 Strengthen scientific evaluation of orphan designation criteria by COMP at the time of MAA 2015 2018 High - publication/availability of additional guidance on the evaluation of significant benefit 1.1-9 Foster research and data generation in the areas of public health needs 2015 2020 Medium - relevant and adequate programmes initiated Work programme 2017 EMA/583016/2016 Page 16/123

Enhance ability to respond 1.1-10 Facilitate early introduction of 2015 2019 High - time between starting point (e.g. Public-health emergencies quickly to public-health emergencies appropriate treatments or preventive measures 1.1-11 Improve Health Threats plan and update post-health-threat activity completion (e.g. Ebola, Zika etc.) application/request for advice) and EMA response (e.g. approval of medicine/SA letter) 2015 2016 Medium - action plan developed and process for rapid answers set up - number of 'lessons' implemented from the 'lessons learned' - rate of completion of post-health-threat activities Minimise risk and impact of 1.1-12 Implement revised action plan 2017 2019 High - implementation of the action plan: level shortages due to manufacturing regarding medicinal product supply of completion of initiatives and Supply issues and availability of new and wellestablished medicines problems and quality defects shortages caused by manufacturing/good manufacturing practice compliance problems, including - harmonised definition (criteria) of shortages - develop metrics for shortages - best practices on communication of shortages - review impact of implementation of tools developed by industry 1.1-13 Develop formal collaboration with WHO in the area of supply disruptions 1.1-14 Support to the European Observatory on the supply of medical radioisotopes proportion of initiatives implemented 2017 2019 Medium - formal agreement with WHO - number of cases worked in collaboration 2017 2019 High - timely input provided to facilitate implementation by the regulatory network of the transition from the use of Work programme 2017 EMA/583016/2016 Page 17/123

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