Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. These products are often ground breaking and aim therapeutic areas where there is a high unmet medical need.
ATMPs are governed by a regulation, Regulation 1394/2007, that sets out rules for their assessment and grants incentives to companies that develop ATMPs. Since ATMPs are often developed by SME’s (micro-, Small and Medium Sized Enterprises) special consideration is given to these.
Bronsing can help you navigate the complex regulatory landscape and help you develop your products for Europe.