Regulatory information – application deadline for participation in information-sharing pilot project for generics extended

21/04/2015

Companies encouraged to submit expressions of interest

The deadline for submitting expressions of interest to participate in the information-sharing initiative for generics has been extended to give more time to companies to submit their applications.

The European Medicines Agency (EMA) launched this initiative in January 2015 for centrally approved products, as part of the International Generic Drug Regulators Pilot (IGDRP) programme. The pilot allows EMA to share its assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the European Union (EU).

Companies are invited to express their interest in participating in the pilot programme using the form provided. The expression of interest should be submitted at least eight weeks in advance of the submission of the related centralised application.

About IGDRP

The IGDRP was launched in April 2012 to strengthen collaboration and convergence between regulatory agencies worldwide and mitigate challenges of global generic development and approval programmes.

This information-sharing initiative is one of the work packages of the IGDRP. It aims to facilitate the timely authorisation and availability of safe, effective and high quality generic medicines worldwide.