The 2010 pharmacovigilance legislation required EMA to publish the format for the electronic submission of information on medicinal products for human use by 2 July 2011.
EMA is more or less on track, and the just-released Electronic submission of information on medicines give a good sense of the four-step approach that the agency will take towards implementation:
Phase one: Notification of the electronic submission format
Phase two: Electronic submission by marketing-authorisation holders
Phase three: Processing and validation of the submitted information
Phase four: Update of the format in compliance with the ISO IDMP standards
For More information click here: Electronic submission of information on medicines
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