EMA announces the launch of the International Generic Drug Regulators Pilot (IGDRP)

A step towards Global Regulatory Harmonisation?


Regulatory Authorities are facing an increasing workload as a result of the growing number of generic applications on one hand, and the demand for accessible, lower-cost quality medicines on the other.

In an attempt to address this issue, Regulatory Authorities have tried to set the grounds for collaboration, towards a faster mechanism for the approval of generic products. As a result, the International Generic Drug Regulators Pilot (IGDRP) was launched in 2012, with the participation of the Regulatory bodies of EU (EMA), USA, Canada, Australia, Singapore, Switzerland, Brazil, China, Chinese Taipei, Republic of Korea, Japan and Mexico. Since its first launch, the Regulatory bodies of New Zealand, Russia and South Africa have also joined the IGDRP.

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.