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Work programme 2017

WC500221614

Results Targets 2014

Results Targets 2014 2015 2016 2017 extensions Additional objectives and activities In addition to delivering its regular post-authorisation 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 postauthorisation changes to marketing authorisations Ensure and run highly effective and efficient processes to deliver post-authorisation activities Further promote use of scientific advice throughout the lifecycle of the product, including further development Strengthen the support in clinical pharmacology and non-clinical aspects to centrally authorised products along their lifecycle 3.2-1 Develop/improve guidance and quality standards for each procedure and deliver internal trainings to ensure regulatory procedural consistency Establish an internal system of knowledge sharing with the aim of providing consistent regulatory advice to the NCAs and MAHs Develop a knowledge sharing system, including for experts, to capture and share the knowledge gained through the initial evaluation and product lifecycle in order to harmonise approaches 3.2-1 Optimise and embed in the Agency the process performance management system with strong customer focus on quality, simplification and regulatory procedural excellence Implement identified improvements to handling procedures for CAPs and NAPs Develop and implement a simplified worksharing procedure for the evaluation of active substance master files used in submissions in centralised and decentralised procedures Optimise processes that include interactions among multiple Committees Create a platform for collaboration with NCAs to understand level of satisfaction and identify improvement opportunities 1.3-6 Analyse the impact of scientific advice on the likelihood of obtaining a positive opinion for extensions of indication Before 2016 After 2017 Q1 2016 2017 Q1 2016 2017 2017 2019 Q1 2016 2018 2016 2017 2017 2018 2017 2018 2017 2018 2017 2018 Work programme 2017 EMA/583016/2016 Page 54/123

Medium-term objective MAWP initiative Activity description Timeframe Start End of authorised medicines (e.g. extensions of indications, postauthorisation safety and efficacy studies) Foster research and data generation in the areas of public health needs 1.1-9 Promote research activities in the area of direct oral anticoagulants (DOACs), thereby using high quality data, information and knowledge to enhance benefit-risk monitoring of the authorised DOACs 2016 2017 Resources 2017 Financial resources (cost, thousand Euro) 90,196 Human resources (FTEs) 92 1.4. Referrals Activity area Referrals are initiated for centrally and nationally authorised products, either in cases where there is concern over the safety or benefit-risk balance of a medicine or a class of medicines, disagreement among Member States on the use of the medicine, a Community interest, or in order to obtain harmonisation within the Union of the conditions of authorisation for products already authorised by Member States. In a referral, the Agency conducts scientific assessment of a medicine (or class of medicines) and makes a recommendation for a harmonised position across the EU. Depending on the type of procedure, the outcome will be implemented by the Member States or the European Commission will issue a decision to all Member States reflecting the measures to take to implement the Agency's recommendation. Referrals can be started by the Commission, any Member State, or by the marketing-authorisation holder that markets the medicine. Drivers The number of referrals is difficult to estimate, given that the drivers are usually unpredictable events. Considering the forecasting challenges for referrals, it is expected that they will remain within the total range of the previous year. High-quality assessment of these procedures is to be maintained, and this raises the challenge of ensuring that data provided by applicants/marketing-authorisation holders are married with additional scientific evidence from different sources to best inform robust decisions on matters of public health. The voice of other important stakeholders, such as healthcare professionals and patients, is also Work programme 2017 EMA/583016/2016 Page 55/123