Cyton's Luisa Pachés-Samblás recently attended this information day at the EMA.
Held at the EMA on 19 April, Ivo Claasen (Head of the Veterinary Division), stressed that despite the EMA’s relocation and the challenges the Agency is facing due to the UK leaving the EU, the EMA is still highly committed to promoting innovation.
Session 1: EU legislative framework for veterinary medicinal products
Josa Nicole Preuss (European Commission) summarised the objectives for the proposed new veterinary legislation, which are: increase availability of VMPs, decrease administrative burden, and tackle antimicrobial resistance. Increasing data protection periods for marketing authorisations was discussed as a potential incentive for innovation. Discussions of proposals received from industry are ongoing at the EC. These include additional data protection for initial MAs for VMPs; at present, the data protection periods proposed for the new regulation are 10 years for major species, 14 years for minor species and 18 years for bees.
The EMA transparency policy was a hot topic. Companies raised concerns on the risk of releasing safety and efficacy data freely. It was feared that companies may be put off from registering their innovative medicinal products in the EU first, as due to the transparency policy their safety and efficacy data could be released and used in a third country. As a consequence, the EU may not be considered the primary region for innovation. David Mackay (EMA) noted that the same level of concern was not shared by the human side.
Session 2: EMA interactions to support innovative medicines
EMA representatives presented findings obtained from questionnaires sent to stakeholders to find out whether companies were aware of the services provided by the Agency to support innovation. They found that although 99% of companies who replied to the questionnaire were aware of the Scientific Advice service, nearly half of stakeholders were not aware of ITF meetings. Both the SME status and MUMS scheme are successful.
Session 3: Interactions with Stakeholders
The role of ADVENT in innovation support was discussed. The feedback on the ADVENT initiative was positive, although it was agreed that new ADVENT topics are needed to help innovation. During this session it was also announced that the EMA website will be run by the European Commission from summer 2018. The EMA expects that the new website will be more user-friendly and provide better search tools.
Full details of the event and presentations from the day can be found on the EMA website.
Training for the development and registration of innovative veterinary medicines
Did you know that Cyton also provides expert training courses? We are looking to run a repeat of our successful event "Development & Registration of Novel Veterinary Therapies". If you would like to know more, please visit our training events page.