Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
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:
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.Audumbar Mali
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
B. Pharm. Final Year, Sem-VIII, BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory),
As PCI Syllabus.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
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..
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
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:
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.Audumbar Mali
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
B. Pharm. Final Year, Sem-VIII, BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory),
As PCI Syllabus.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
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..
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
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
Nicely described regarding about the overview of ICH guidelines as per PCI syllabus specially for Pharmacy students not only for pharmacy student for all. It include Quality, Safety, Efficacy & Multidisciplinary guidelines and also include Common Technical Document & Electronic Common Technical Document.
Military Commissions details LtCol Thomas Jasper as Detailed Defense CounselThomas (Tom) Jasper
Military Commissions Trial Judiciary, Guantanamo Bay, Cuba. Notice of the Chief Defense Counsel's detailing of LtCol Thomas F. Jasper, Jr. USMC, as Detailed Defense Counsel for Abd Al Hadi Al-Iraqi on 6 August 2014 in the case of United States v. Hadi al Iraqi (10026)
WINDING UP of COMPANY, Modes of DissolutionKHURRAMWALI
Winding up, also known as liquidation, refers to the legal and financial process of dissolving a company. It involves ceasing operations, selling assets, settling debts, and ultimately removing the company from the official business registry.
Here's a breakdown of the key aspects of winding up:
Reasons for Winding Up:
Insolvency: This is the most common reason, where the company cannot pay its debts. Creditors may initiate a compulsory winding up to recover their dues.
Voluntary Closure: The owners may decide to close the company due to reasons like reaching business goals, facing losses, or merging with another company.
Deadlock: If shareholders or directors cannot agree on how to run the company, a court may order a winding up.
Types of Winding Up:
Voluntary Winding Up: This is initiated by the company's shareholders through a resolution passed by a majority vote. There are two main types:
Members' Voluntary Winding Up: The company is solvent (has enough assets to pay off its debts) and shareholders will receive any remaining assets after debts are settled.
Creditors' Voluntary Winding Up: The company is insolvent and creditors will be prioritized in receiving payment from the sale of assets.
Compulsory Winding Up: This is initiated by a court order, typically at the request of creditors, government agencies, or even by the company itself if it's insolvent.
Process of Winding Up:
Appointment of Liquidator: A qualified professional is appointed to oversee the winding-up process. They are responsible for selling assets, paying off debts, and distributing any remaining funds.
Cease Trading: The company stops its regular business operations.
Notification of Creditors: Creditors are informed about the winding up and invited to submit their claims.
Sale of Assets: The company's assets are sold to generate cash to pay off creditors.
Payment of Debts: Creditors are paid according to a set order of priority, with secured creditors receiving payment before unsecured creditors.
Distribution to Shareholders: If there are any remaining funds after all debts are settled, they are distributed to shareholders according to their ownership stake.
Dissolution: Once all claims are settled and distributions made, the company is officially dissolved and removed from the business register.
Impact of Winding Up:
Employees: Employees will likely lose their jobs during the winding-up process.
Creditors: Creditors may not recover their debts in full, especially if the company is insolvent.
Shareholders: Shareholders may not receive any payout if the company's debts exceed its assets.
Winding up is a complex legal and financial process that can have significant consequences for all parties involved. It's important to seek professional legal and financial advice when considering winding up a company.
Car Accident Injury Do I Have a Case....Knowyourright
Every year, thousands of Minnesotans are injured in car accidents. These injuries can be severe – even life-changing. Under Minnesota law, you can pursue compensation through a personal injury lawsuit.
2. CONTENT :
Introduction to CTD
Structure of CTD
Orgnization of CTD
Module of CTD
eCTD
Characterstics of eCTD
Format of eCTD
Advantage of eCTD
Difference between eCTD and CTD
Reference
*
3. Objective of
CTD
The objective is to increase international
harmonization of technical requirements
to ensure that safe, effective, and high
quality medicines are developed and
registered in the most efficient and cost‐
effective manner.
*
4. European Medicines Agency (EMEA, Europe)
Food and Drug Administration (FDA, USA)
Ministry of Health, Labour and Welfare
(MHLW Japan).
CTD
CTD is a joint effort of 3 Regulatory
Agencies-
*
5. The Common Technical Document (CTD) is a
set of specification for application dossier for
the registration of Medicines and designed to
be used across Europe, Japan and the United
States
CTD
*
6. 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
*
7. All sentences should blue Italic fonts
Font Size 12 in Times new roman ( Descriptive Text )
Font size 9 in Times new roman ( Table content and Text)
Text and tables should be prepared using margins.(Pravent binding
problem )
All pages of a document should include a unique header or footer
GENERAL CONSIDERATION
*
8. GENERAL CONSIDERATION
Hard copy: front and side of each volume / file / binder must contain
Name of applicant , file no , date of submission and drug name .
E.g- file No 6/10 (file no / total file )
Thickness of file should not more then 3 inches
CDs should be labeled using marker (Name of applicant , file no ,
date of submission and drug name )
Applicant should preserve duplicate copy for future reference
Submit ONE hard copy and THREE soft copies
*
10. ORGANISATIONS OF CTD:
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
*
11. Module 1
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.
Administrative Information (Region
Specific )
*
12. 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
*
13. It contain 7 sections in the following
order
2.1 CTD TOC
2.2 CTD Introduction
2.3 Quality Overall Summary
2.4 Nonclinical overview
2.5 Clinical overview
2.6 Non clinical summary
2.7 Clinical summary
Module 2
*
14. Module 3
Quality [CMC]
3.1 TOC of Module 3
3.2 Body of Data
3.2.SDrug substance
3.2.P Drug product
3.2.A Appendices
3.2.R Regional information
3.3 Literature references *
15. 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
*
16. 5.1 TOC of Module 5
5.2 Tabular listing of clinical studies
5.3 Clinical study reports
Module 5
Clinical Study Reports
*
17. • 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
Module 5
Clinical Study Reports
*
18. e CTD
It is electronic version of CTD , so called as electronic
common technical document
e CTD composed of 2 types of specification
1. Content specification – As defined by ICH
2. Technical specification- Electronic
softwares
CTD
e CTD
TOC[pdf]
[paper] XML
Backbone *
19. eCTD highly recommended by USFDA for
NDAs, DMFs, and NDAs filing
From 2010 EU also make compulsory
eCTD to all procedure
CTD eCTD
Module 1 m1
Module 2 m2
Module 3 m3
Module 4 m4
Module 5 m5
*
20. .
Why electronic?
Improve the submission and review process
Increase accuracy of the submission
Decrease total costs
This specification has been developed by the
ICH M2 Expert Working group and maintained
by the eCTD Implementation Working group in
accordance with the ICH Process.
*
21. e CTD Characteristics
• 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
*
23. Advantage of eCTD
Improved handling and archiving of submissions
Large reduction in dossier duplication time and
expense .
Ease of archiving and distribution
Immediate Access to complete and up to date‐ ‐
information
*
24. Advantage of eCTD
Ease of navigation during review using hyperlinks
and bookmarks .
Facilitated evaluation and better visibility of the
process
Reduced workload and reuse of information for
assessment reports
Reduced the time for filing submissions and reduce
time to market
*
25. CTD eCTD
Compiled electronically with volumes ,
tabs , slipsheets then printed to paper
Compiled electronically with e documents
in folders
Paper volumes must be A4 e Documents can be A4 or US letter size
CTD navigation by TOC s and volume e CTD navigation by XML backbone
Cross references includes target CTD
section number
Cross references are hyperlinked to
targets
Manual document navigation by TOC s,
page numbers, and caption cross
references
Electronic document navigation by TOC s
,bookmarks and hyperlinks
Submitted in binders in boxes on pallets
by trucks
Submitted on CD[ or DVD] or by email or
portal
*
26. REFERENCE
Patel R.C. et.al. An eCTD filing for generic drug application in USA
JOURNAL OF PHARMACEUTICAL SCIENCE AND BIOSCIENTIFIC
RESEARCH (JPSBR )Volume 4, Issue 4: 2014(228-236)
Jordan D. An overview of the Common Technical Document (CTD)
regulatory dossier The European Medical Writers Association Volume 23
2014 (101-105)
ICH M4 Guidelines Organization of Common Technical Document for the
registration of Pharmaceuticals for human use (R3) [cited 2004 Jan 13]
ICH M8 Guidelines : Electronic common technical document [cited 2010
Nov 8]
*