Guidance for Submission v 4 - SFDA

Guidance for Submission

Version 4.0

March 2014

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Guidance for Submission

Version 4.0

Drug Sector Saudi Food & Drug Authority

Kingdom of Saudi Arabia

Please visit SFDA's website at for the latest update

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Drug Sector

Vision & Mission

Vision

To be the leading regional Drug Regulatory Authority for pharmaceuticals and cosmetic products, with professional excellence and services that contribute to the protection and advancement of public health in the Kingdom of Saudi Arabia.

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Mission

Protecting public health by ensuring safety, quality, efficacy and accessibility of human, veterinary drugs and biological products, and safety of cosmetics, through administration of a national regulatory system which is consistent with international best practice. Through our mission, we also provide accurate and scientific-based information to the public and healthcare professionals.

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Document Control

Version

1.0 1.1 1.2 1.3

2.0 2.1 2.2 2.3 2.4

3.0 3.1 3.2 4.0

Date

11/05/2009 20/05/2009 06/06/2009 28/06/2009 08/07/2009 20/7/2010 18/9/2011 2/12/2011 7/12/2011 17/12/2011 08/05/2012 10/10/2012 16/03/2014

Author(s)

Licensing department Licensing department Licensing department Licensing department Licensing department Regulatory Affairs Regulatory Affairs Regulatory Affairs Regulatory Affairs Regulatory Affairs Regulatory Affairs Regulatory Affairs Regulatory Affairs

Comments

Initial draft for internal consultation Draft revision Draft revision Revisions after management discussion Published for comments Internal revision External consultation Final revision Approved by management Published Updated and Published version Updated version Final version posted

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