Panion has renewed the status as Small- and Medium-sized Enterprise (SME) in the European Medicines Agency (EMA) for one more year, until the end of 2019. The application is free for the company and gives access to an increased level of advice and assistance during development and registration of medicines for the EU market. Fee waivers and fee reductions for several procedures, e.g. scientific advice, are available for SME applicants. Panion benefitted from meeting with the Innovation Task Force in EMA in June 2018.
Background: EMA is committed to fostering an environment supportive to SMEs and their stakeholders, as it implements the action plans for small and medium-sized enterprises, advanced therapies medicines and academia within the frameworks for interactions with industry stakeholders and academia. Assistance was provided through the SME Office helpdesk, email correspondence, teleconferences or meetings.
SME briefing meetings provide a platform for assistance to enterprises which are new to the EU regulatory approval system and facilitate early interaction with the Agency. They provide an opportunity for SMEs to informally discuss a planned regulatory strategy and development programme.
A total of 1893 SMEs were registered with EMA at year end 2017, and 4% of these develop veterinary medicines. In 2017, 35 % of all veterinary marketing authorisation applications in EMA were submitted by SMEs (6 out of 17). Of the finalised authorisation procedures in 2017 from SMEs for veterinary medicines, there were 2 positive opinions and no negative outcomes.