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Work programme 2017

WC500221614

Medium-term objective

Medium-term objective MAWP initiative Activity description Timeframe Start End Provide and further promote continuous and consistent preapplication support to applicants, including through collaboration with international partners Support development and availability of veterinary medicines measures recently put in place to support innovation (ADVENT, ITF) 2.1-6 Publish Q&A developed by ADVENT in priority areas for technologies that are new to veterinary medicine (including cell-based therapies, monoclonal antibodies for veterinary use) Explore the scope for developing specific regulatory approaches to facilitate authorisation of alternatives to antimicrobials to control infectious disease in animals 2.1-5 Explore ways to promote the uptake of parallel scientific advice with the FDA, as part of pre-submission advice 2.1-2 Implement EMA contribution to the EU Network Strategy to 2020 in the area of promoting availability of vaccines within the EU, with particular emphasis on vaccines against transboundary diseases and diseases with limited markets Before 2016 After 2018 2017 2018 Before After 2015 2018 2016 2020 Resources 2017 Financial resources (cost, thousand Euro) 1,310 Human resources (FTEs) 2 2.2. Initial evaluation Activity area Initial evaluation refers to the process of scientific assessment of applications for veterinary medicines submitted for marketing authorisation through the centralised procedure. The following activities are included in this domain. • Initial evaluation. The initial evaluation phase includes pre-submission discussions with future applicants, scientific evaluation of applications, and issuing an opinion to the European Commission. The Commission grants the marketing authorisation, following which the Agency publishes a European public assessment report (EPAR). • Establishment of MRLs. The use of veterinary medicinal products in food-producing animals may result in the presence of residues in foodstuffs obtained from treated animals. Before a veterinary Work programme 2017 EMA/583016/2016 Page 68/123

medicinal product can be authorised, the safety of its residues must be evaluated. The Agency establishes maximum residue limits (MRLs) for pharmacologically active substances used in veterinary medicines, as well as for certain biocidal products used in animal husbandry, to ensure consumer safety with regard to foodstuffs of animal origin, including meat, fish, milk, eggs and honey. Drivers The Agency expects to see continued interest in submission of applications for marketing authorisation for innovative veterinary medicinal products, including therapies that are completely new to veterinary medicine. These will present particular challenges for the Committee for Medicinal Products for Veterinary Use (CVMP) in terms of benefit-risk assessment. The number of applications for new MRLs is expected to remain at a similar level, indicating continuous interest in the industry in developing new veterinary medicines for food-producing animals. Streamlined business processes will be implemented in 2017 to provide increased harmonisation and efficiency in procedures. Workload indicators Results Forecasts 2014 2015 2016 2017 Initial evaluation applications 12 10 21 24 New MRL applications 4 4 6 2 MRL extension and modification applications 2 3 1 2 MRL extrapolations 2 1 0 1 Art 10, Biocides 0 0 0 2 Review of draft Codex MRLs 5 0 5 0 Performance indicators Results Targets 2014 2015 2016 2017 Procedures completed within legal timeframes 100% 100% 100% 100% Additional objectives and activities In addition to delivering its regular initial evaluation activities for veterinary products, the Agency plans to undertake and progress the following activities: Medium-term objective MAWP initiative Activity description Timeframe Start End Provide high quality and 2.2-7 Finalise development of revised guideline, Before 2017 consistent scientific outputs of the EMA procedures and templates for CVMP assessment reports and provide training on these 2015 Ensure the establishment of 2.1-9 Provide technical support to the European Before 2018 Work programme 2017 EMA/583016/2016 Page 69/123

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