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Work programme 2017

WC500221614

Workload indicators Results Forecasts 2014 2015 2016 2017 Herbal monographs, new 11 14 8 5 Herbal monographs, revised 5 3 9 15 List entries 1 0 2 1 Performance indicators Results Targets 2014 2015 2016 2017 n/a Additional objectives and activities Medium-term objective MAWP initiative Activity description Timeframe Start End Implement the Clinical Trials Regulation (EU) No 536/2014* Support high level of coordinated cross-European preparedness to act upon public health threats Facilitate development of new antibiotics for treatment of multi-resistant bacteria, including through enhanced international cooperation Strengthen the quality of the scientific review processes Promote application of harmonised international standards Ensure needs of specific populations are met, including 1.3-2 Finalise the new and revised guidelines related to the implementation of the Clinical Trials Regulation, considering as applicable the comments received during public consultation 1.1-11 Issue specific working procedures on handling emerging health threats, in line with the new structure and plan 3.2-15 Provide scientific support to writing a new guideline on paediatric aspects of new antibiotics and to revision of SmPCs for already approved antibiotics 3.2-14 Establish a pragmatic approach setting European standards for herbal combination products 3.2-15 Provide technical and scientific contribution to the development of an addendum to the ICH guideline E9 statistical principles in clinical trials, and the finalisation of the ICH guideline E17 on multi-regional clinical trials Provide technical and scientific contribution to the development of ICH safety guidelines (Carcinogenicity assessment document evaluation for ICH S1) 1.1-7 Develop and implement EMA strategy for medicine safety in pregnancy 2015 2017 2015 After 2017 2016 2018 2016 2018 Before 2017 2015 Before After 2015 2017 2016 After 2018 Work programme 2017 EMA/583016/2016 Page 62/123

Medium-term objective MAWP Activity description Timeframe initiative Start End elderly, children, patients with rare diseases and others * For information on the IT systems required by the Clinical trials regulation, please see section 1.7. Projects Resources 2017 Financial resources (cost, thousand Euro) 13,790 Human resources (FTEs) 23 1.7. Projects In order to support the Agency's work and achievement of set objectives, a number of programmes and projects will be undertaken. The table below details the main projects, their timelines and deliverables that the Agency will pursue in 2017. The main projects in 2017 will be related to: • Pharmacovigilance. The main focus will be on building and implementing the enhanced EudraVigilance system to deliver adverse drug reaction (ADR) and signal-management capability for the network in 2017. • Clinical trials. In August 2017, an audit of the EU Portal and Database will take place enabling the Clinical Trials Regulation to become applicable by October 2018. Following the audit, improvement of the system will continue. • eCollaboration. The focus in 2017 will be on finalising the eCTD v4.0 standard, and implementing the single entry point for electronic submissions for the network through integration of the EMA's gateway and the CESP. Programme / Legal basis Start End Deliverables 2017 Project date date Pharmacovigilance programme EudraVigilance auditable requirements EudraVigilance critical requirements • Directive 2001/83/EC, art.107 • Regulation (EC) 726/2004, art.24 • Commission implementing regulation (EU) 520/2012, art.18, 23, 25-28 and chapter V • Directive 2001/83/EC, art.107 • Regulation (EC) 726/2004, art.24 • Commission implementing regulation (EU) 520/2012, art. 23, 25 and 26 Q4 2013 2018 • Audit of new EudraVigilance system • PRAC recommendation on the EV system audit results • Agency move to simplified reporting • Mandatory reporting of non-serious cases in EudraVigilance • Data submission to WHO • Switch of eRMR functionalities Q4 2013 - Project on hold until after 2018 Work programme 2017 EMA/583016/2016 Page 63/123

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