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Drug M
File (DMF):
Guidance for
Submission
Version 1.0
August2014
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DrugSector
SaudiFood&DrugAuthority
KingdomofSaudiArabia
PleasevisitSFDAswebsiteathttp://www.sfda.gov.sa/En/Drugforthelatest
update
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Drug Sector
Vision
TobetheleadingregionalDrugRegulatoryAuthorityforpharmaceuticalsandcosmetic
products,withprofessionalexcellenceandservicesthatcontributetotheprotectionand
advancementofpublichealthintheKingdomofSaudiArabia.
Mission
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Document Control
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Table of Contents
1 Introduction ................................................................................................................ 7
2 Scope ............................................................................................................................ 8
3 Definitions.................................................................................................................. 9
4 Content of Drug Master File ....................................................................................10
4.1 Cover letters: ...............................................................................................................10
4.2 Letter of Access: ..........................................................................................................10
5 Presentation of the Drug master file ........................................................................12
5.1Language:.................................................................................................................12
5.2SoftcopyRequirements:...........................................................................................12
5.3Numberofcopies:....................................................................................................12
5.4Media:......................................................................................................................12
6 Delivery to SFDA ......................................................................................................13
7 Contact Address .........................................................................................................14
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1 Introduction
The Drug Sector in the Saudi Food & Drug Authority (SFDA) has developed
this document, Drug Master File (DMF): Guidance for Submission, to provide
assistance for stakeholders on how to submit them. This document is an
administrative instrument that outlines the requirements of DMF submissions to be
submitted to the SFDA.
It is important to note that the SFDA reserves the right to request information,
material or defined conditions not specifically described in this document, in order
to allow the administration to adequately assess the safety, efficacy and quality of
drug products. The SFDA is committed to ensuring that such requests are
justifiable and decisions are clearly documented.
This document should be read in conjunction with the other relevant and
applicable guidance documents. A copy of this document can be found on our
website:
http://www.sfda.gov.sa/en/drug/drug_reg/Pages/drug_reg.aspx
The SFDA is fully committed to an orderly process for the review and
authorization of pharmaceutical products, and we are working to develop
procedures to implement those aspects of the initiative. We are also committed to
assuring that stakeholders remain fully informed of our progress as we implement
the initiative.
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2 Scope
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3 Definitions
Drug Master File (DMF) A file that is used to provide confidential detailed
information about facilities, processes, or articles used in
the manufacturing, processing, packaging, and storing of
one or more human drugs. DMFs usually cover the
Chemistry, Manufacturing and Controls (CMC) of a
component of a drug product e.g. drug substance,
Excipient, packaging material.
1
Alldrugapplicationisgivencertainabbreviationwithasequencenumberaccordingtotheirtype
asfollows:
HN:HumanNewdrug
HB:HumanBiologicaldrug
HG:HumanGenericdrug
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d) Date of submission2
f) Trade name2
i) Address
Before SFDA can review DMF information in support of an application, the DMF
holder shall submit a letter of authorization permitting SFDA to reference the
DMF.
2
TheinformationcanbeobtainedfromtheapplicantwhosubmittedafiletoSFDA
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e) Trade Name3
h) Address
Notes:
3
TheinformationcanbeobtainedfromtheapplicantwhosubmittedafiletoSFDA
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5.1 Language:
For the softcopy (electronic-based), each CD or DVD and its hard plastic
cover submitted should include the following label information, clearly
presented and printed on the media with the font of 12 Times New Roman (or
equivalent):
5.4 Media:
Refer to the Guidance for Submission version 4.0 from page 15 to 17.
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6 Delivery to SFDA
Saudi Arabia
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7 Contact Address
Saudi Arabia
Fax: +966-11-275-7195
e-mail: sdr.drug@sfda.gov.sa
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