European regulation has changed in recent years to push industrial companies to develop and sell medicinal products that tackle rare or ultra-rare diseases. These measures include credit allocation and clinical research support.
To be registered, all orphan drugs must go through a centralized procedure to obtain a European MA issued by the EMA. At the end of this process, a 10-year period of exclusivity is granted in Europe.
It should be noted that obtaining a centralized MA does not mean that this medicinal product will be marketed because it is up to MA holders to initiate the procedures at the national level for each Member State where they intend to market their product.