Oncology Products – Barriers to Success

oncologyCancer is the leading cause of death in UK and as consequence extensive research has been conducted into potential cures and treatments.

Certainly, it is clear that cancer is a very complex and dynamic disease with vast numbers of different types of cancers, nearly all of them currently incurable.

INFARMED’S Pre-Submission Portal for New Marketing Authorisation Applications

Updated user’s guidance issued on February 2014
Portugal_flag_300In August 2013, INFARMED introduced a new electronic portal for pre-submission of new Marketing Authorisation Applications (Medicinal Products for Human Use Management System-MAA: SMUH-AIM). The use of the portal became mandatory on November 4th for all applications through a national procedure, a Repeat-Use Procedure where Portugal would act as the RMS or a Mutual Recognition/Decentralised procedure where Portugal would act as an RMS or CMS.