RSNN Expert Meeting Report - Regulatory challenges for non-biological complex drugs (NBCDs)

The RSNN expert meeting discussed and elaborated potential research questions on the theme of ‘Regulatory challenges for complex generic products’. Fourteen experts were invited in a personal capacity to discuss this theme in an informal setting. The diverse list of participants included regulatory experts, clinical experts, academic professionals and representatives of the innovative and generic industries.

The expert meeting discussion focussed on 3 key points:

• the role and importance of scientific advice
• what is the correct authorisation procedure?
• other important aspects

A number of research questions on those key points were formulated during the expert meeting. These will be incorporated in future research agendas to inform policy discussions.

The full report of the expert meeting can be downloaded here: PDF (English) | PDF (Dutch)