The document summarizes key aspects of a drug dossier submission process. It explains that a dossier contains detailed information about a drug product that is submitted to regulatory authorities for market approval. It also describes the Common Technical Document (CTD) format, which is a harmonized template used for presenting dossier data. The CTD includes 5 modules that cover administrative information, summaries, quality, non-clinical studies, and clinical studies. Electronic CTD (eCTD) submissions using an XML backbone are now commonly accepted by major regulatory agencies.

1. A PRESENTATION ON
DOSSIER
Prepared By:
Ankush Singh
CCP232303
M. Pharm R.A.
Semester Ist
TOPICS:
1. Paper submissions
2. Overview & Modules of CTD
3. Electronic CTD submissions
Submitted To:
Deepika Mam

2. DOSSIER
• A dossier is a file document that contains detailed information about a drug product and
is submitted to the regulatory authorities.
• It is a set of records and data summarizing the entire history of product production &
evolution.
• The market approval of a drug product depends upon the dossier.
• It is the vehicle to the regulatory agency for the product approval.
• The dossier submission is done after the successful completion of the phase III clinical
trials.
• It is submitted in various forms like CTD, eCTD, ACTD, NeeS, etc.
• CTD is a harmonized format (template) for presenting data in the ICH regions.

3. PAPER SUBMISSIONS
• Although the eCTD format is now accepted in lieu of paper submission and eCTD or NeeS
formats are accepted in many EU member states for dossier submissions, a paper copy of
the dossier is still a legal requirement in some countries. e.g., TGA
• In the past, paper submissions were produced following the paper-based CTD format,
effectively necessitating the production of two different submissions if an eCTD or NeeS
was to be submitted.
• The considerable additional work (and associated costs) entailed in producing a
submission in two fundamentally different formats significantly impeded the
implementation and adoption of electronic submissions by industry.
• It is mutually accepted that the only solution to this problem is to allow applicants to use
the eCTD or NeeS as the antecedent submission, from which the official paper submission
is then printed.

4. • Printing the eCTD or NeeS as per the directions will fulfil the requirements of regulatory
authorities requiring paper for legal or archiving purposes.
• Many EU countries recognize the electronic submission in eCTD or NeeS format as the
legally valid submission - any printed material serves solely as a review aid and thus has
no legal standing.
• However, where the paper submission is the legally valid submission, or where local
regulations require that a paper dossier is provided, then it is the responsibility of the
applicant to produce a valid.
• The structure of a printed copy of the eCTD or NeeS should be in accordance with the
sequence of documents as referenced in the XML backbone of the eCTD or the overall
Table of Contents (TOC) of the NeeS.
• This sequence of documents should be in line with CTD guidance and there should be
one Cover Letter included in the paper dossier.
• The number of paper submission dossier copies required varies according to the type of
submission.

5. OVERVIEW OF CTD
• A Common Technical Document (CTD) is a well-structured, globally accepted common
format maintained by the ICH with regard to technical criteria for the registration of
human pharmaceuticals.
• It is an ICH-defined format that has been agreed upon and accepted by regulatory
agencies in Europe, Japan, and the United States.
• It is a supporting list of leaflets that must be given to the regulatory body with
pharmaceutical registration applications to obtain market authorization.
• The FDA defines the CTD as an information package containing clinical, non-clinical,
manufacturing, and technical data that would be submitted for registration of novel
pharmaceuticals in all three ICH regions, namely the United States, the European Union,
and Japan.
• CDSCO has also decided to adopt CTD format for technical requirements for registration
of pharmaceutical products for human use.

6. MODULES OF CTD
The Common Technical Document is organized into five modules:

7. Module 1: Regional & Administrative Data
• It includes administrative documents particular to each region, such as application
forms, legal documents or the proposed regional designation.
• It is not considered to be a section of CTD.
Module 2: CTD Overview & Summaries
• This module consists of the CTD summary containing 7 sections.
i. Section 1 – Table of Contents
ii. Section 2 – Introduction
iii. Section 3 – Quality overall summary
iv. Section 4 – Non-clinical overview
v. Section 5 – Clinical overview
vi. Section 6 – Non-clinical written and tabulated summaries
vii. Section 7 – Clinical summary

8. Module 3: Quality
• It contains:
i. Table of Contents
ii. Body of data containing detailed information pertaining to quality of drug
substance(s), drug product, excipients, facility & equipment.
• Drug substance(s) contains information about:
i. General information
ii. Manufacturing of drug substance
iii. Characteristic of drug substance
iv. Quality control of drug substance
v. Reference standard materials
vi. Container closure system
vii. Stability of drug substance

9. • Drug product contains:
i. Composition of drug product
ii. Pharmaceutical development of drug product
iii. Manufacturing of drug product
iv. Control of excipients
v. Control of drug product
vi. Reference standard material
vii. Stability of drug product
Module 4: Non-clinical study reports
• It contains:
i. Table of Contents
ii. Study reports about pharmacology, pharmacokinetics & toxicology.

10. • Pharmacology information contains:
i. Primary pharmacodynamics
ii. Secondary pharmacodynamics
iii. Safety pharmacology
iv. Pharmacodynamic drug interaction
• Toxicology information contains:
i. Single-dose toxicity
ii. Repeat-dose toxicity
iii. Carcinogenicity
iv. Reproductive & Development toxicity

11. Module 5: Clinical study reports
• It contains:
i. Table of Contents
ii. Tabular listing of all studies
iii. Clinical study reports
• Clinical study reports contains information about:
i. Reports of BABE, IVIVC studies
ii. Reports of pharmacokinetic-pharmacodynamic studies
iii. Reports of efficacy & safety
iv. Reports of post-marketing experience

12. eCTD SUBMISSION
• Electronic Common Technical Document (eCTD) is the electronic form of a common
technical document which is submitted by the applicant to the regulatory agency in order
to obtain approval for marketing the drug.
• It is made up of individual PDF documents that are structured in accordance with the CTD
structure.
• The information is provided by cross-linking the document using XML backbone.
• It is superior technology and is a single application format for all applications.
• The eCTD submissions are highly transparent, easy to navigate and review.
• eCTD submissions are accepted by major countries such as the US, Europe, Australia,
Canada, South Africa, Thailand, and Japan as a standard format.

13. eCTD Structure
• Modules - 1 to 5
• Documents - PDF linked via XML backbone
Significance of eCTD
• It helps in easy reviewing of the application and helps to avoid the omission of the data.
• The review or communication of regulatory agencies is done in time.
• It is a common format which is being accepted in all countries.
End of Presentation