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Work programme 2017

WC500221614

Increase access to data

Increase access to data for 1.4-3 Take forward discussion on making 2016 2018 Medium - draft reflection paper prepared and delivery of regulatory activities available individual patient data from clinical trials endorsed by the Management Board 1.4-4 Explore the potential use of real-world 2016 2020 High - number of new data sources used in databases, electronic healthcare regulatory activities/decision-making records and 'big data' Increase transparency of the 1.4-5 Implement clinical data policy and 2014 2019 Critical/ - availability of clinical trial work of the network provisions of the Clinical Trials urgent data/information Regulation regarding the transparency and availability of clinical trial data 1.4-6 Improve provision of information to 2011 2017 High - better information to patients patients and prescribers Transparency 1.4-7 Increase transparency on the work done during authorisation procedures to assess and manage risks to the environment arising from the use of medicines 2015 2019 Medium - level of acceptance/implementation of new benefit-risk template in assessment report Work programme 2017 EMA/583016/2016 Page 22/123

Theme 2: Contributing to animal health and human health in relation to veterinary medicines Objective 1: Increase availability of veterinary medicines and promote development of innovative medicines and new technologies Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Availability of veterinary medicines Provide support and incentives for development of new medicines for MUMS/limited markets Support development and availability of veterinary medicines Explore ways to limit attrition of existing products Explore new ways for specific sectors to improve availability 2.1-1 Provide a clear framework to industry on the classification and incentives for authorisation of products indicated for MUMS/limited markets 2015 2017 High - increased number/proportion of MUMS marketing-authorisation applications and MUMS products on the market - publication of the revised MUMS/limited markets guidelines 2.1-2 Identify and implement EMA 2016 2020 High - increased number of pre-submission contribution to the EU Network requests and submissions of MAAs for Strategy to 2020 in the area of vaccines in general and those against promoting availability of vaccines transboundary diseases in particular within the EU - completion of actions assigned to EMA/CVMP in the Joint EMA/HMA Action Plan on Availability of Veterinary vaccines 2.1-10 Participate in the HMA/EMA Task Force 2016 2020 High - completion of actions assigned to EMA on Availability of authorised medicines in the Joint EMA/HMA Task Force on for human and veterinary use Availability of authorised medicines for human and veterinary use 2.1-3 Develop with the network a strategy 2016 2017 Medium - pilot project on extrapolation of data on and action plan to support retention on existing antimicrobials to promote their the market of long-used veterinary retention on the market antimicrobials - 2.1-4 Provide CVMP feedback on gap analysis 2016 2020 Medium - regulatory activities initiated to address from the FishMed Plus coalition on identified gaps in the availability of fish availability of fish medicines medicines 2.1-11 Explore with relevant stakeholders 2016 2020 Medium - reflection paper on antiparasitic Work programme 2017 EMA/583016/2016 Page 23/123

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