This document discusses dossier preparation and submission for regulatory approval of pharmaceutical products. It defines a dossier as a collection of documents on a subject used to propose approval of a new drug. Dossiers contain administrative, quality, nonclinical, and clinical data. Common dossier formats include CTD, ACTD, and eCTD, which are used globally and in various regions. Careful compilation, review, and planning is required to ensure dossiers meet all regulatory requirements for submission.

1. DOSSIER PREPARATION AND SUBMISSION
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2. DOSSIER PREPARATION AND SUBMISSION
SUBMITTED BY:
POOJA RATHEE
DRA 2nd Semester
MD UNIVERSITY ROHTAK
SUBMITTED TO:
PROF. SANJU NANDA
PHARMACEUTICS
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3. CONTENTS:
• INTRODUCTION TO DOSSIER & REGISTRATION DOSSIER
• CONTENTS OF DOSSIER
• GOALS OF DOSSIER
• COMMON DOSSIERS USED IN P’CEUTICAL INDUSTRY
• DESCRIPTION OF VARIOUS FORMAT DOSSIERS
• DOSSIER MANAGEMENT
• COMPILATION AND REVIEW OF DOSSIER
• REGULATORY SUBMISSIONS
• PLANNING AND PREPARATION OF REGULATORY SUBMISSIONS
• REVIEW ASPECTS FOR REGULATORY SUBMISSIONS
• BINDERS IN PHARMACEUTICAL INDUSTRY
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4. “Dossier”
• BASICALLY Dossier is a collection or file of documents
on the same subject, especially a file containing
detailed information about a person or a topic.
• In REGULATORY…. Dossiers are the vehicle in a
country through which drug sponsors formally
propose that the Regulatory Agencies approve a new
pharmaceutical for sale and marketing.
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5. “Registration Dossier”
• “Registration Dossier” of the pharmaceutical product is a
document that contains all the technical data
(administrative, quality, nonclinical and clinical) of a
pharmaceutical product to be approved / registered /
marketed in a country. It is more commonly called as the
New Drug Application (NDA) in the USA or Marketing
Authorization Application (MAA) in the European Union
(EU) and other countries, or simply Registration Dossier.
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6. CONTENTS OF DOSSIER
• Data proving that the drug has quality, efficacy and
safety properties suitable for the intended use
• Any Additional administrative documents
• Samples of finished product
• Related substances and reagents necessary to
perform analyzes of finished product
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7. Goals of the Dossiers
• Is the drug safe and effective in its proposed use(s) when
used as directed, and do the benefits of the drug
outweigh the risks?
• Is the drug’s proposed labeling (package insert)
appropriate, and what it contain?
• Are the methods used in manufacturing (Good
Manufacturing Practice, GMP) the drug and the controls
used to maintain the drug’s quality adequate to preserve
the drug’s identity, strength, quality, and purity?
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8. ATTENTION PLEASE…………..
• Every country has its own regulatory authority, which is responsible to
enforce the rules and regulations and issue the guidelines to regulate the
marketing of the drugs. The single regulatory approach for marketing
authorization application (MAA) of a new drug product applicable to
various countries (on the basis of single dossier) is utmost difficult.
• Therefore, the knowledge of exact and detailed regulatory requirements
for MAA of each country should be known to establish a suitable
regulatory strategy.
Submission of applications, which do not comply with the
prescribed requirements, may result in delays, queries or
rejection of registration.
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9. Common Pharmaceutical Dossier which is widely used
in the Pharmaceutical Industry are:
CTD Dossier
ACTD Dossier
eCTD Dossier
Country Specific Registration Dossier
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10. CTD Format Dossiers
•This Format of Dossier is an Important & widely used
Dossier format in most of the country, This format of any
registration application for Marketing Authorization
Dossier is submitted to Food and Drug Authority or
Ministry of health or any other equivalent authority along
with other required documents.
•CTD Format Dossier is widely used in semi regulated &
regulated market like CIS Countries, Middle East
countries, European Union, USA , Australia, African
Countries, Canada, Japan, etc 10

11. Common Technical Document Consists of the following Modules with the
number of the required Documents.
Module 1 – Administrative Information &
Prescribing Information
Module 2 - Common Technical Documents
Summaries
Module 3 –Quality
Module 4 – Non Clinical Study Report
Module 5 – Clinical Study Report
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12. ACTD Format Dossiers
• ASEAN CTD Dossier, ASEAN Common Technical Dossier (ACTD) provides a common
format for the preparation of well-structured Common Technical Dossier
applications for submission in ASEAN regulatory authorities for the registration of
pharmaceuticals for human use.
• ACTD format significantly reduce the time and resources needed to compile
applications for registration.
• Regulatory reviews and communication with the applicant is facilitated by a
standard document of common elements.
This guideline merely demonstrates an appropriate write-up format for acquired
data. However, applicants can modify, if needed, to provide the best possible
presentation of the technical information, in order to facilitate the understanding
and evaluation of the results upon pharmaceutical registration.
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13. Asian Common Technical Documents consists of following parts.
Part I – Administrative Data
and Product Information
Part II – Quality Documents
Part III – Non Clinical
Documents
Part IV – Clinical Documents.
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14. • ACTD Format is Asian harmonization for Common
technical Documents used in
Brunei Darussalam, Cambodia, Indonesia, Laos,
Myanmar, Malaysia, Philippines, Singapore, Thailand
and Vietnam.
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15. eCTD Format Dossier
• This format of Registration Dossier is an electronic format for CTD Dossier,
• Submission in eCTD format should be in accordance with the current ICH
M2 EWG eCTD specification,
• Electronic files should be in accordance with the Guidance for Industry on
Providing Regulatory Information in Electronic Format.
• The eCTD is an interface for the pharmaceutical industry to transfer
regulatory information with various regulatory agencies.
• The content is based on the Common Technical Document (CTD) format.
• It was developed by the International Conference on Harmonisation (ICH)
Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).
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16. o The US FDA and Europe EMEA announced that the
eCTD is the preferred format for electronic
submission (eSubmisson) of Drug Dossiers. The drug
manufacturer has to submit the drug dossier in eCTD
format.
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19. NeeS format Dossier
• Requirements for the submission of Non-eCTD
electronic Submissions (NeeS). A separate EU
guidance document covering eCTD submissions,
which is regarded as the principal electronic
submission format in EU.
A NeeS format submission can normally be started
with any initial, variation or renewal MA submission.
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20. • Once the switch to this electronic format is made it is
expected that further applications and responses relating
to the particular medicinal product are submitted in
NeeS format. Applicants can switch from NeeS to eCTD at
the start of any new regulatory activity. Applicants should
however not change from eCTD back to NeeS.
There is no requirement to reformat the whole dossier
into NeeS format when switching from paper to NeeS,
but this could be done at the applicant’s discretion.
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23. Country Specific Format Dossier
• This format of Registration Dossier is in accordance
with the Specific Country Regulatory Guidelines.
• Compile and write entire dossier of specified
modules as per Guidelines provided by the
Government Regulatory Authorities.
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25. Importance of effective dossier management-
• The registration dossier for medicines is an important document which is
submitted for review to regulatory agencies by pharma companies for
approval to market their medicines.
• Utmost care should be taken during its compilation and filing as it plays a
direct role in earliest possible availability of medicines in the market which
in turn translates into business for the company.
• Regulatory affairs professionals need to ensure the safety, quality and
efficacy of the medicines for which they are filing registration dossier.
• Note : The dossiers could be anything among DMF,
ASMF, ANDA, NDA or MAA.
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26. Compilation
The following compilation aspects are important-
– The information should be specific, clear, precise and
accurate.
– Typographical and grammatical errors should be avoided.
– The information should be arranged in a sequential order
in computer. Each module could have a separate folder
and in turn each section of a module could have a separate
folder. This kind of orderly arrangement will help in easy
access of information and help in taking printouts
of finalized copy conveniently.
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27. Continued……
• The line spacing should be preferably single.
• All the documents received from other departments should
be cross-checked so as to ensure that they are free from
errors.
• Ensuring the specifications & test procedures are designed in
accordance with ICH guidelines Q3A, Q3B, Q3C, Q6A and Q6B.
• Stability Protocols are designed as per ICH guidelines Q1A
through Q1E . Similarly ensuring that various documents are
designed as per ICH guidelines. This can be ensured during
drafting stages of preparation of various documents.
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28. Continued……
• After the finalized soft copy is ready, printouts should be
taken using a good quality printer and
arranged sequentially in a module and section wise
manner.
• As per the note given in the website of EMA-"All
Microsoft Office documents submitted to the European
Medicines Agency must be in a format compatible with
MS Office 2003. Office 2007 and Office 2010 formats
cannot currently be accepted".*
*:not confirm in the year 2018
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29. Review Aspects
• Every human being is prone to make mistakes; hence it is important to re
check the information in the dossier before filing it with regulatory agencies.
• It is also important that a dossier meant to be filed with a regulatory agency should
be cross verified by a person other than the one who has complied the dossier.
• It is very useful to have a check list so as to ensure that all the required
information is present in the dossier before submission to regulatory agency.
• The USFDA has a check list which is very useful while filing an ANDA- ANDA
checklist
• The module 1 of CTD in most of the cases is completely different for various
agencies hence care should be taken in compiling this section.
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30. Regulatory Submissions
• A regulatory submission for a healthcare
product includes any documentation or information
submitted to a regulatory agency for review, for
notification or in response to a request for additional
information related to a healthcare product.
• The format can be paper or electronic, or both.
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31. Types of regulatory submissions
• Licensing applications for drug, biologics or devices
• Clinical trial applications
• Requests for orphan drug or fast-track designations
• Requests for protocol assistance
• Responses to agency questions that arise during the review;
for example, clarifaxes, deficiency letter, requests for
additional information
• Post-approval studies or commitments
• Amendment/variation applications or notification submissions
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32. Planning and preparation of regulatory submission
• Before preparing any regulatory submission, identify
the relevant regulatory requirements so that you can
ensure your submission will comply. Note that the
requirements for drug and medical
device submissions are quite different.
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33. Continued……
• Who is the regulatory agency and what is the review division for
healthcare product?
• What are the regulatory requirements that govern submission?
• What kind of information should be included? Is there a guidance
document available that details the format and content
requirements of the submission?
• Where to send the submission?
• How many copies should submit?
• For hard-copy submissions, are there requirements regarding
binding?
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34. REVIEW ASPECTS FOR REGULATORY SUBMISSION:
• As the submission should facilitate the regulatory review, organize the information so that it
is easy to read and properly sectioned. Have it support navigation so the reviewer can quickly
find what they need. Where applicable, consider using these elements:
– Cover letter
– Table of contents
– Volume and page numbers
– Clear headings and subheadings
– Table and figure numbers, with accurate references to them from within the text
– Tabs that aid quick finding of the submission sections
– Reader-friendly font sizes, types and colours
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35. • It is useful to always provide a concise summary at
the start to “set the stage” for the submission.
– Such information may highlight a very brief product
description, the proposed indication, the intended patient
population, the purpose of the submission (for example, a
modification to an existing device design) or any key
information that could assist the reviewer’s understanding
prior to the review.
• Ensure that content is clearly legible and that submissions
are properly bound using binders acceptable to the
regulatory agency
• Lastly, if any source document is in another language, ensure
you provide an appropriate translation
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36. •BINDERS IN PHARMACEUTICAL INDUSTRY
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37. REFERENCES:-
http://ich.org/
http://www.ema.europa.eu/
http://www.fda.gov
http://nebula.wsimg.com/30d111f7e6ba8359d5c583c16f6dcce9?AccessKeyId=2643E0535E
29763819D5&disposition=0&alloworigin=1
https://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm083621.html
http://www.regulatoryone.com/2011/11/effective-dossier-management.html
http://www.sgregulatory.com/dossier.html
https://www.marsdd.com/mars-library/pre-submission-regulatory-meetings-preparation/
https://www.marsdd.com/mars-library/drug-submissions-procedures-to-reach-regulatory-approval/
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