1 year ago

Work programme 2017


Ensuring the adequate

Ensuring the adequate availability of a wide range of high-quality, safe and effective veterinary medicines remains the highest priority for regulators within the European Union. The European Commission has proposed ambitious changes to the legal framework for veterinary medicines, designed to ensure that legislation is adapted over the next few years to the particular needs of the veterinary domain, where this is needed. Novel therapies that were previously seen only in the human domain are starting to make their way into veterinary medicine, and the Agency will need to harness the expertise of the network to develop or adapt regulatory requirements to make the European market attractive for this type of product. Identifying if there is a need to develop specific regulatory approaches to facilitate the authorisation of novel products that represent alternative to the use of antimicrobials will be an area of particular focus. Work will continue on facilitating access to the market for products for minor use in major species or for use in minor species (MUMS), providing fee reductions for those products considered of most benefit to animal or public health. Particular attention will be given to tackling the challenges that exist in bringing new vaccines to market and in ensuring that authorised vaccines are available to deal rapidly with incursions of exotic disease, the risk of which has increased substantially in recent years. Finally, the Agency will also improve on the procedures for management of incidents relating to veterinary medicines within the EU that have the potential to create crisis situations in terms of animal or public health or lack of availability. This objective will be achieved through close cooperation with the Network through the European Surveillance Strategy Group, taking into account recent experience and considering in particular how to improve communication around crises within the Network and with stakeholders. The experience gained in managing shortages in supply of essential human medicines will be reviewed to adapt existing systems or to develop new approaches specifically designed to minimise the impact of problems in the supply chain of essential veterinary medicines. Stakeholder involvement and transparency With a multitude of stakeholders involved from the early stages of development through to patients accessing and using medicines, the Agency continuously works to interact with and involve stakeholders in the regulatory processes in the best ways possible. Patients, consumers, animal owners and healthcare professionals demand high levels of transparency, and more and better information to support their decision-making. Society wants to see the outcomes of clinical trials, pharmacovigilance and other stages of the medicines lifecycle. All aspects of the work of the Agency, from the initial evaluation through to post-authorisation monitoring, are becoming subject to more intense scrutiny by stakeholders and the community as a whole. Following the implementation of relevant legislative provisions, patients and healthcare professionals are represented in the corporate governance of the Agency, Management Board and certain scientific committees. In addition, the Agency closely cooperates with its various stakeholders, including healthcare professionals' organisations, patients and consumers' organisations, scientific and academic societies, and the pharmaceutical industry. To ensure that stakeholders' relations are guided by key principles of transparency, independence and appropriate interaction, formal frameworks for interacting with patients, healthcare professionals, the pharmaceutical industry and academia have been developed and are currently being implemented. These frameworks collectively offer a platform for exchange and multi-stakeholder dialogue at the European level. Capturing patient values and preferences in the benefit-risk assessment of medicines, and understanding better the clinical use of medicines once on the market, will contribute to the quality of the scientific opinions we adopt. The implementation of public hearings will allow the Agency to reach Work programme 2017 EMA/583016/2016 Page 10/123

out to civil society, allowing citizens to voice their views, while further transparency initiatives will promote a better understanding of the decision-making process. Work programme 2017 EMA/583016/2016 Page 11/123

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