The document summarizes the Common Technical Document (CTD) format used for drug registration submissions to regulatory agencies in the US, EU, and Japan. It describes the five modules of the CTD, including Module 1 for administrative information, Module 2 for summaries, Module 3 for quality information, Module 4 for nonclinical study reports, and Module 5 for clinical study reports. It then discusses the electronic CTD (eCTD) format, which uses an XML backbone to link PDF documents electronically for improved review efficiency compared to the paper CTD format.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be 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.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be 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.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
common technical document and electronic document by akshay trivedi
The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The Common Technical Document is divided into five modules: Administrative and prescribing information
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documen- tation included in an application for the registration of a human pharmaceutical product..
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
CTD is common technical document for submission of dossier and widely accepted format for ease of submission and evaluation purpose.
TRS 961, Annex 15, Guidelines on submission of documentation for a multisource (generic) finished product. General format: preparation of product dossiers in common technical document format
Objectives of CTD guidelines
To significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals
To facilitate regulatory reviews and communication with the applicant by a standard document of common elements
To simplify the exchange of regulatory information between Regulatory Authorities
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
Common Technical Document (CTD) serves as a set of specifications for application dossier for the registration of medicines, and designed to be used across Europe, Japan and the United States. The guidelines for CTD are provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). TSDP provides clinical medical writing training on preparation of CTD.
Embracing GenAI - A Strategic ImperativePeter Windle
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Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
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Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
1. Presentation by : Pawankumar Hanamant Yadav
1st year M. Pharm (sem –l)
Dept. : Pharmaceutics
Guided by : Mr. K. J. Kore
Subject : Regulatory Affairs
RAJGAD DNYANPEETH’s
COLLEGE OF PHARMACY , BHOR
4. •Common Technical Document [CTD]: It is an format
set by ICH which was agreed by the Regulatory
Agencies of Europe , Japan & the U.S.
• The FDA characterized the CTD as “An information
package of clinical, non clinical , manufacturing ,
technical data in the same content that would be
submitted for registering new drugs in all 3 ICH
regions i.e. U.S,European Union and Japan
CTD
5. • It should be organized into 5 modules
-Module 1 – Administrative Information
[Region Specific]
-Module 2 – CTD Summaries[QOS]
-Module 3 – Quality[CMC]
-Module 4 – Non clinical study reports
-Module 5 – Clinical study reports
Organisations Of CTD
6. • This module should contain documents
specific to each region
• Ex : Application form regarding the
prescribing information, proposed label
• This module is not part of the CTD.
•The content & format of this module can be
specified by the relevant regulatory authorities.
MODULE 1
Administrative Information [Region Specific
7. MODULE 2
CTD Summaries [QOS]
• It should begin with a general introduction to the
pharmaceutical , including its pharmacological
class , mode of action & proposed clinical use. i.e.
information should not exceed one page
• It contain 7 sections in the following order:
-2.1 CTD TOC [Module 2 – 5] [Table Of Content]
- 2.2 CTD Introduction
- 2.3 Quality Overall Summary
8. -2.4 Nonclinical overview
-2.5 Clinical overview
-2.6 Non clinical summary
-2.7 Clinical summary
• The organization of these summaries is
described in 3 separate documents:
A] M4 Q – The CTD quality
B] M4 S - The CTD Safety
C] M4 E - The CTD Efficacy
9. MODULE 3
Quality [CMC]
• 3.1 TOC of Module 3
• 3.2 Body of Data
-3.2.S -Drug substance
-3.2.P – Drug product
-3.2.A – Appendices
- 3.2.R –Regional information
• 3.3 Literature references
10. MODULE 4
Non Clinical Study Reports
• 4.1 TOC of Module 4
• 4.2 Study reports
-4.2.1 pharmacology
-4.2.2 pharmacokinetics
-4.2.3 Toxicology
• 4.3 Literature References
11. MODULE 5
Clinical Study Reports
• 5.1 TOC of Module 5
• 5.2 Tabular listing of clinical studies
• 5.3 Clinical study reports
-5.3.1 Repots of biopharmaceutical study[BA-BE]
-5.3.2 Reports of PK [biomaterial] study
-5.3.3 Reports of PK studies
-5.3.4 Reports of PD studies
-5.3.5 Reports of Efficacy and safety studies
-5.3.6 Reports of Post marketing experience
-5.3.7 Case Report forms & Individual patient listings
• 5.4 Literature References
12. eCTD
• It is electronic version of CTD , so called as
electronic common technical document [e CTD]
• e CTD composed of 2 types of specification
-Content specification – As defined by ICH
-Technical specification- Electronic softwares
CTD TOC [pdf] [paper]
eCTD XML Backbone
13. •eCTD is highly recommended by USFDA for
NDAs, BLAs, DMFs and INDs filing
•From year 2019 European Union also make
compulsory for electronic CTD submission
to all procedures
CTD eCTD
Module 1 m1
Module 2 m2
Module 3 m3
Module 4 m4
Module 5 m5
14. • Structure
-All Modules 1 to 5 have granularity options.
-PDF documents linked via XML backbone.
-Increased document granularity.
-Transparency of entire submission.
-Ease of navigation and review.
eCTD Characteristics
15. Benefits of eCTD
•Improve reviewer efficiency.
•Can reduce time to approval.
•Improved handling and achieving of submissions(both
sponsor and FDA).
•Search functionality and increased tracking ability.
•Allows for repurposing of docs for submission in other
regions.
•Accessibility to docuents across modules.
•Submission via ESG allows immediate receipt by FDA.
16. COMPARING PAPER CTD AND e CT
Paper CTD eCTD
Compiled electronically with
volumes, tabs, sheets, then
printed to paper.
Complied electronically with
a documents in folders.
Paper volumes must be A4. eDocuments can be A4 or
US letter size.
CTD navigations by TOCs
and volume.
eCTD navigation by XML
backbone.
Manual document
navigation by TOCs, page
numbers, caption cross
references.
Electronic document
navigation by TOCs,
bookmarks and hyperlinks.
Cross reference includes
target CTDsection number.
Cross references are
hyperlinked to targets.
Submitted in binders in
boxes on pallets by trucks.
Submitted on CD or DVD or
by email or portal.
