eCTD Glossary

0-9 A B C D E F G H I J K L M N O P Q R S T U V W XY Z


Volltextsuche: nur in Begriffsliste suchen



Einträge 1 bis 3 von 3

I:
ICH
ICH M2 EWG
IRISS
 
ICH
Internation Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Joint initiative involving regulators and researched-based industry from the so-called ICH regions EU, US and Japan. ICH was created in April 1990 at a meeting in Brussels, Europe. The purpose of ICH is to avoid unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. The CTD is maintained by the ICH.
 



© 2007 - 2017 | Exalon GmbH | Fritz-Reichle-Ring 2 | 78315 Radolfzell | Germany | Phone: +49 (0)7732.939.1650 | Fax: -.1655 | e-Mail:info@exalon.com