Orphan drugs are those for relatively rare indications. Special procedures and incentives apply to their registration, to encourage pharmaceutical companies to develop them. This module provides information necessary to enable the preparation of applications for orphan drug status in the EU and USA. The procedures for making an application are detailed, including the collection of supporting data and the acquisition of protocol assistance. In Europe the Centralised Procedure is now the mandatory route to gain marketing authorisation for orphan products. This module will serve as a useful reference tool to keep abreast of the impact of the new regulatory requirements.


Who will benefit from this module?
All staff in the pharmaceutical industry who are inexperienced in regulatory affairs and compliance will find the module an invaluable introductory training course. More experienced personnel will find it a useful reference tool.