Early interactions procedures with regulators have been established to support medicines’ development and mainly innovative medicines, and the specific challenges they face. The support comes in the form of services and regulatory procedures allowing medicines’ developers to interact with the regulators through existing mechanisms during the development of a medicinal product.
Here, we present some of those mechanisms that apply to innovative medicines including Advanced Therapy Medicinal Products (see: Support for innovative medicines’ development and sub-entries within), as well as mechanisms that are specific to Advanced Therapy Medicinal Products (ATMP) (see: Support specific to ATMP's development at EMA level).