A new Guidance
detailing practical and technical points related to the submission and handling
of an ASMF (Active Substance Master File - previously also known as European
Drug Master File, EDMF) in eCTD format has been drafted by a joint working
group comprising representatives from EU Regulatory Authorities, the EMA,
industry, EDQM and ASMF holders.
The Guidance is available as final draft version and comments from stakeholders are actively sought. The objective is to update the guidance as necessary in July 2010. Comments should be sent to esubmission@mpa.se.
To find more information please use the below mentioned web link
http://www.exalon.com/index.php?id=69&tx_ttnews%5Bpointer%5D=3&tx_ttnews%5Btt_news%5D=128&tx_ttnews%5BbackPid%5D=68&cHash=f8e67301d1
The Guidance is available as final draft version and comments from stakeholders are actively sought. The objective is to update the guidance as necessary in July 2010. Comments should be sent to esubmission@mpa.se.
To find more information please use the below mentioned web link
http://www.exalon.com/index.php?id=69&tx_ttnews%5Bpointer%5D=3&tx_ttnews%5Btt_news%5D=128&tx_ttnews%5BbackPid%5D=68&cHash=f8e67301d1
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