Small Molecules Procedures
Since 2005 companies who intend to market a product
in the European Union in more than one Member State
have the choice to use the most suitable procedure
for a new molecular entity. New small molecules can
go either the central or the decentralised
way. If the intended indication, however, belongs to
the treatment of diabetes, neurodegenerative diseases
(e.g. Alzheimer), cancer, viral diseases or is an orphan,
the centralised procedure is mandatory.
Each procedure carries both advantages and disadvantages. The wrong choice can be costly and time-consuming and lead to sub-optimal performance of the company.
It is our aim to help companies define the right regulatory pathway by taking into consideration issues like:
