Please login to the form below

Not currently logged in
Email:
Password:

EC consults on orphan drug application guidelines

Also seeks input on the transfer of designations from one sponsor to another

The European Commission (EC) has put its proposed guideline on the format and content of applications for orphan drug status out to public consultation.

The proposed guideline provides supplementary advice on how to compile the documents that should be provided by sponsors in an application for orphan medicinal product designation

It also covers the provision of advice to sponsors wishing to transfer the designation of an orphan medicinal product and/or to change the name or address of a sponsor.

• Comments and suggestions are invited by September, 30 and should emailed to: sanco-pharmaceuticals-d5@ec.europa.eu

19th July 2013

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Quintiles Medical Communications

Quintiles’ award-winning medical communications group sits at the heart of the enterprise. We offer a range of innovative strategic services,...

Latest intelligence

women
Advancing women in healthcare
Fostering the next generation of leaders...
The Challenges Of UX In Healthcare: Technology To Change Lives
Blue Latitude Health Director and Head of Customer Experience Elisa Del Galdo explores the latest digital healthcare trends and reveals the innovations changing the sector today....
It’s all about patient outcomes… right?
Lessons from history: a design thinking perspective...

Infographics