Micro, small and medium-sized enterprises or SMEs are a driver of innovation in the pharmaceutical sector and play a key role in the development of new medicines. However, finding their way through EU rules and regulations can sometimes be challenging.
EMA addresses the unique needs of these companies through its SME office, which provides regulatory, financial and administrative assistance to small pharmaceutical companies.
EMA has prepared and published a short video to explain how this dedicated office helps SMEs across Europe. Fee incentives for regulatory procedures submitted to the Agency or translations of product information in all European Union languages are among the benefits.