Master

Drug M
File (DMF):
Guidance for
Submission
Version 1.0

August2014



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Drug Master File (DMF): Guidance for

Submission
Version1.0

DrugSector

SaudiFood&DrugAuthority

KingdomofSaudiArabia



PleasevisitSFDAswebsiteathttp://www.sfda.gov.sa/En/Drugforthelatest
update

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Drug Sector

Vision & Mission

Vision

TobetheleadingregionalDrugRegulatoryAuthorityforpharmaceuticalsandcosmetic
products,withprofessionalexcellenceandservicesthatcontributetotheprotectionand
advancementofpublichealthintheKingdomofSaudiArabia.

Mission

Protectingpublic healthbyensuringsafety,quality,efficacyand accessibility ofhuman,

veterinarydrugsandbiologicalproducts,andsafetyofcosmetics,throughadministration
of a national regulatory system which is consistent with international best practice.
Through our mission, we also provide accurate and scientificbased information to the
publicandhealthcareprofessionals.

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Document Control

Version Date Author(s) Comments

0.1 11/6/2014 Licensing department Initial draft for internal consultation
0.2 7/8/2014 Evaluation department 1st review
0.3 17/8/2014 Licensing department 2nd review
1.0 18/8/2014 Licensing department Approved, and published for comments

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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

This guidance document applies to Drug Substance, Drug Substance Intermediate,

and Material Used in their Preparation, or Drug Product.

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3 Definitions

Agent or representative Any person who is appointed by a DMF holder to serve

as the contact for the DMF holder.

Applicant The company or its representative.

Authority The Saudi Food and Drug Authority (SFDA).

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.

Drug product Finished dosage form tablet, capsule, or solution etc

which contain a drug substance.

GCC-DR Gulf Cooperation Council Drug Registration

Holder Person who owns a DMF.

Letter of access written statement by the holder or designated agent or

representative permitting SFDA to refer to information
in the DMF in support of another person's submission.

Reference number1 Any combination of letters and numbers that is assigned

to the transaction in order to follow it.

Registration number A number (or combination of letters and numbers) that is

given to a registered product by the SFDA.

1
Alldrugapplicationisgivencertainabbreviationwithasequencenumberaccordingtotheirtype
asfollows:
HN:HumanNewdrug
HB:HumanBiologicaldrug
HG:HumanGenericdrug

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4 Content of Drug Master File

The DMF content shall be composed of the following:

4.1 Cover letters:

The following should be included:

a) Identification of submission: new, renew or variation

b) Procedure Type: National (SFDA) or Central (GCC-DR) procedure

c) Registration or Reference number2

d) Date of submission2

e) Active substance name

f) Trade name2

g) DMF holder name

h) Manufacturer name (if different from DMF holder name)

i) Address

j) Typewritten name and title of the signer

k) Signature of the authorized representative

4.2 Letter of Access:

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.

The letter of access should include the following:

a) Identification of submission: new, renew or variation

b) Procedure Type: National (SFDA) or Central (GCC-DR) procedure

c) Registration or Reference number

d) Active substance name

2
TheinformationcanbeobtainedfromtheapplicantwhosubmittedafiletoSFDA

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e) Trade Name3

f) DMF holder name

g) Manufacturer Name (if different from DMF holder name

h) Address

i) Typewritten name and title of the signer

j) Signature of the authorized representative

Notes:

Cover letter and letter of access must be on company letterhead paper.

If there is more than one manufacturing site, list all sites.

3
TheinformationcanbeobtainedfromtheapplicantwhosubmittedafiletoSFDA

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5 Presentation of the Drug master file

A softcopy (electronic-based) of the DMF is only required, along with a

hardcopy of the cover letter and letter of access:

5.1 Language:

Information and documents supporting a drug application such as

certificates and approval letters must be either in Arabic or English. If
documents are neither in Arabic nor English, a translation to English (from an
authorized translation office).

5.2 Softcopy Requirements:

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):

The reference numbers

The company name
The Generic name

5.3 Number of copies:

Applicants should submit ONE softcopy. The submission shall be in ONE

media only (CD or DVD) i.e. if the submission size was above 750MB then the
applicant has to use a DVD.

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

DMF submissions and correspondence should be addressed as follows:

Regulatory Affairs department

Executive Licensing department

Drug Sector - Saudi Food and Drug Authority

3292 North ring road

Al Nafal Unit (1)

Riyadh 13312 6288

Saudi Arabia

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7 Contact Address

Saudi Food and Drug Authority Drug Sector

3292 Northern Ring Road An nafal District

Riyadh 13312 6288

Saudi Arabia

Tel: +966-11-203- 8222 extensions: 5788 , 5739, 5335

Fax: +966-11-275-7195

e-mail: sdr.drug@sfda.gov.sa

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