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

August 2014 
 

    This page is left blank intentionally Aug 2014  Saudi Food & Drug Authority    2  .

0              Drug Sector  Saudi Food & Drug Authority  Kingdom of Saudi Arabia        Please visit SFDA’s website at http://www.sfda.   Drug Master File (DMF): Guidance for Submission Version 1.sa/En/Drug for the latest  update  Aug 2014  Saudi Food & Drug Authority    3  .gov.

   Through  our  mission. quality.  we  also  provide  accurate  and  scientific‐based  information  to  the  public and healthcare professionals. and safety of cosmetics. efficacy and  accessibility  of human.‫א‬‫א‬‫א‬‫א‬‫א‬               Aug 2014  Saudi Food & Drug Authority    4  . with professional excellence and services that contribute to the protection and  advancement of public health in the Kingdom of Saudi Arabia.    ‫א‬    ،‫א‬ ‫א‬ ‫א‬  ‫א‬   ‫א‬‫א‬ ‫א‬‫א‬      K‫א‬‫א‬‫א‬‫א‬   Mission  Protecting public  health by ensuring safety.   Drug Sector Vision & Mission   Vision  To be the leading regional Drug Regulatory Authority for pharmaceuticals and cosmetic  products.  veterinary drugs and biological products. through administration  of  a  national  regulatory  system  which  is  consistent  with  international  best  practice.   ‫א‬ ‫א‬‫א‬‫א‬‫א‬‫א‬‫א‬‫א‬ ‫א‬  ‫א‬ ‫א‬   ‫א‬      ‫א‬ ‫א‬   .

and published for comments                                         Aug 2014  Saudi Food & Drug Authority    5  .1 11/6/2014 Licensing department Initial draft for internal consultation 0.3 17/8/2014 Licensing department 2nd review 1.0 18/8/2014 Licensing department Approved.2 7/8/2014 Evaluation department 1st review 0.     Document Control Version Date Author(s) Comments 0.

............. 8  3  Definitions....................................................................................................................................................................................12  5................ 12  5...............................................................   Table of Contents   1  Introduction ....................... 12  6  Delivery to SFDA ....................................................................13  7 Contact Address .......................1 Language: ................................................ 7  2  Scope ...........................2 Letter of Access: ................................................................ 12  5...................................................................................10  4.............................................................................................4 Media: ...............................................................................................10  5  Presentation of the Drug master file ..........................................................................................................................................2 Softcopy Requirements: ................................................................................................. 12  5....14  Aug 2014  Saudi Food & Drug Authority    6  ...................3 Number of copies: ..................................................................................................1 Cover letters: ................10  4............................................................................................................................................................................... 9  4  Content of Drug Master File ................

aspx The SFDA is fully committed to an orderly process for the review and authorization of pharmaceutical products. This document is an administrative instrument that outlines the requirements of DMF submissions to be submitted to the SFDA. The SFDA is committed to ensuring that such requests are justifiable and decisions are clearly documented.sa/en/drug/drug_reg/Pages/drug_reg. material or defined conditions not specifically described in this document. It is important to note that the SFDA reserves the right to request information. in order to allow the administration to adequately assess the safety. to provide assistance for stakeholders on how to submit them. We are also committed to assuring that stakeholders remain fully informed of our progress as we implement the initiative.sfda. This document should be read in conjunction with the other relevant and applicable guidance documents. efficacy and quality of drug products. ‘Drug Master File (DMF): Guidance for Submission’.gov. and we are working to develop procedures to implement those aspects of the initiative.   1 Introduction The Drug Sector in the Saudi Food & Drug Authority (SFDA) has developed this document.     Aug 2014  Saudi Food & Drug Authority    7  . A copy of this document can be found on our website: http://www.

or Drug Product. Aug 2014  Saudi Food & Drug Authority    8  .   2 Scope This guidance document applies to Drug Substance. and Material Used in their Preparation. Drug Substance Intermediate.

capsule.g. Authority The Saudi Food and Drug Authority (SFDA). Applicant The company or its representative. Drug Master File (DMF) A file that is used to provide confidential detailed information about facilities. or solution etc… which contain a drug substance. Reference number1 Any combination of letters and numbers that is assigned to the transaction in order to follow it. drug substance. Excipient. or articles used in the manufacturing. Manufacturing and Controls (CMC) of a component of a drug product e. DMFs usually cover the Chemistry. Drug product Finished dosage form tablet.                                                              1  All drug application is given certain abbreviation with a sequence number according to their type  as follows:  HN: Human – New drug  HB: Human – Biological drug  HG: Human – Generic drug  Aug 2014  Saudi Food & Drug Authority    9  . 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. processing. processes. packaging material.   3 Definitions Agent or representative Any person who is appointed by a DMF holder to serve as the contact for the DMF holder. and storing of one or more human drugs. GCC-DR Gulf Cooperation Council Drug Registration Holder Person who owns a DMF. Registration number A number (or combination of letters and numbers) that is given to a registered product by the SFDA. packaging.

  4 Content of Drug Master File The DMF content shall be composed of the following: 4. renew or variation b) Procedure Type: National (SFDA) or Central (GCC-DR) procedure c) Registration or Reference number d) Active substance name                                                              2  The information can be obtained from the applicant who submitted a file to SFDA  Aug 2014  Saudi Food & Drug Authority    10  . The letter of access should include the following: a) Identification of submission: new.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. the DMF holder shall submit a letter of authorization permitting SFDA to reference the DMF.2 Letter of Access: Before SFDA can review DMF information in support of an application.

 If there is more than one manufacturing site.                                                                        3  The information can be obtained from the applicant who submitted a file to SFDA  Aug 2014  Saudi Food & Drug Authority    11  .   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. list all sites.

if the submission size was above 750MB then the applicant has to use a DVD. If documents are neither in Arabic nor English.2 Softcopy Requirements: For the softcopy (electronic-based). 5. 5. a translation to English (from an authorized translation office). along with a hardcopy of the cover letter and letter of access: 5.     Aug 2014  Saudi Food & Drug Authority    12  .   5 Presentation of the Drug master file A softcopy (electronic-based) of the DMF is only required. The submission shall be in ONE media only (CD or DVD) i.1 Language: Information and documents supporting a drug application – such as certificates and approval letters– must be either in Arabic or English.e. 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 5.4 Media: Refer to the ‘Guidance for Submission’ version 4. each CD or DVD and its hard plastic cover submitted should include the following label information.0 from page 15 to 17.3 Number of copies: Applicants should submit ONE softcopy.

Saudi Food and Drug Authority 3292 North ring road Al Nafal Unit (1) Riyadh 13312 – 6288 Saudi Arabia Aug 2014  Saudi Food & Drug Authority    13  .   6 Delivery to SFDA DMF submissions and correspondence should be addressed as follows: Regulatory Affairs department Executive Licensing department Drug Sector .

gov.drug@sfda.   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 .sa Aug 2014  Saudi Food & Drug Authority    14  . 5335 Fax: +966-11-275-7195 e-mail: sdr. 5739.