1. Fundamentals of Electronic Submissions and eCTD
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2. Fundamentals of Electronic Submissions and eCTD
Today's Presentation will be spreadover
three main topics as below:
Regulatory Guidance
eCTD Technicalities
Gap Analysis
(in-house current regulatory operations vs recommended eCTD based regulatory operations)

3. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
Some Definition
Submissions Formats
• Paper
Full submission in Hard copy as printed Text
• Electronic
Submission in CTD folder structure in a CD /DVD
with or without supporting Hard copies for legal
or other requirements of the individual Agency
• eCTD
Submission of Documents with a Xml backbone
sent eitherin a CD/DVD or uploaded in the agencys’ portal
(the definitions can be with animation )

4. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
Need For Regulatory Guidance
The Constant changing Drug registration requirements is entering an Electronic Era
The Scientists and Industry Experts require exposure on the current Electronic Documentation Practices
This is the integration of Technical Knowledge, Regulatory Requirements and Information technology

5. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
INTRODUCTION
Regulatory guidance on legislation and regulations:
Regulatory guidance such as laws, decrees, orders and any legislative and regulatory material related to pharmacy, drug manufacturing, drug registration process, commerce, information, promotion and advertising, e-trade is available
( this slide may not be required at this place)

6. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
MAJOR AGENCIES IN REGULATED MARKET
US: FOOD AND DRUG ADMINISTRATION (FDA)
EU: EUROPEAN MEDICINES EVALUTION AGENCY
(EMEA)
EUROPEAN DIRECTORATE FOR QUALITY
MEDICINES (EDQM)
JAPAN: MINISTRY OF HEALTH ,LABOUR ANDWELFARE
(MHLW)
CANADA: HEALTH PRODUCT AND FOOD BRANCH
(HEALTH CANADA)

7. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
Web link to Drug regulatory sites:
(one of the various sites in the net giving lists of Drug regulatory Agencies world wide)

8. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
Submission Types
Investigational New Drug Application
(IND)
New Drug Application
(NDA/ NDS)
Abbreviated/Abridged New Drug Application
(ANDA/ ANDS)
Drug Master Files (DMF)
Active Substance Master File (ASMF)

9. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
Large no of documents +
Different format for Different Agencies
means
More complication to Manufacturer
Solution = Harmonisation of document
ICH

10. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
HISTORY & ROLE of ICH:
ICH is – The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use in the year ----
First initiative to streamline the technical requirements for drug regulatory registrations
A Joint effort of Regulatory authorities and industry association

11. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
HISTORY & ROLE of ICH… continued
Initiated by
6 Parties from European Union, Japan and USA
-the EU, EFPIA, MHLW, JPMA, FDA and PhRMA.
3 Observers are WHO, EFTA, and Canada (represented by Health Canada)
- acting as a link between the ICH and non-ICH
countries and regions.

12. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
HISTORY & ROLE of ICH… continued
ICH Guidelines:
The ICH Topics are divided into four major categories
Q "Quality" Topics,
- relating to chemical and pharmaceutical QualityAssurance.
S "Safety" Topics,
- relating to in vitro and in vivo pre-clinical studies.
E "Efficacy" Topics,
- relating to clinical studies in human subject.
M "Multidisciplinary" Topics,
- cross-cutting Topics which do not fit uniquely into one of the
above categories.

13. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance
HISTORY & ROLE of ICH… continued
M "Multidisciplinary" Topics, are grouped as
M1: Medical Terminology (MedDRA)
M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)
M3: Timing of Pre-clinical Studies in Relation to Clinical Trials
M4: The Common Technical Document (CTD)
M5: Data Elements and Standards for Drug Dictionaries

14. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance

15. Fundamentals of Electronic Submissions and eCTD Regulatory Guidance

16. Fundamentals of Electronic Submissions and eCTD eCTD Technicalities

17. Fundamentals of Electronic Submissions and eCTD Gap Analysis

18. DRUG MASTER FILES
Thank You