Transcript Common Technical Document (CTD)

Common Technical
Document
(CTD)
Presented by: -
SHRUTI SHAH
M.Pharm
Department of Pharmaceutics and
pharmaceutical technology
L.M. College of Pharmacy
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What is CTD?
Why CTD?
Preparing and organizing the CTD
Guidance for industry
What is the current status of CTD?
ICH – Status of harmonized initiatives
ICH – eCTD
Implementations within the three ICH regions
Conclusion
Advantages of CTD
Not included in CTD
Limitations
Benefits
Questions
References
What is CTD?
 Application format
 CTD is an internationally agreed “well
structured common format” for the
organization of the technical
requirements that is to be submitted to
the regulatory authority as an
application for the registration of
pharmaceuticals for human use in all
three ICH regions (U.S.A., Europe and
Japan).
November 2000 at ICH5 in San
Diego
Harmonization – in technical
requirement
Therefore, generating and
compiling different registration
dossiers can be avoided
Why CTD?
To provide a harmonized common
format/template for the submission
of technical requirement to the
regulatory authorities (FDA) that is
acceptable in all 3 ICH regions
Reduce the time and resources used to
compile applications
It will ease the preparation of
electronic submissions.
To facilitate simultaneous
submission in three regions.
To facilitate exchange of
regulatory information.
 Faster availability of new
medicines
Preparing & Organization of CTD
It is organized into:-
• Module
• Module
• Module
• Module
2:
3:
4:
5:
CTD summaries
Quality
Nonclinical reports
Clinical reports
The CTD
Triangle
Module 1.
Administrative information and
prescribing information.
Document specific to each region.
E.g. Application form
Proposed label for use in the
region
Module 2. CTD summaries
2.1 Table of content
2.2 Introduction
2.3 Quality overall summaries
2.4 Non-clinical overview
2.5 Clinical overview
2.6 Non-clinical summaries
2.7 Clinical summaries
2.3 Quality overall summaries
Should provide the reviewer
with an overview of module 3.
Should identify the critical
key parameters and give
justification where guidelines
are not followed.
2.4 Non-clinical overview
Non-clinical data with it’s
interpretation
Clinical relevance of findings
Implications of the findings
for the safe use of the
product.
2.5 Clinical overview
Summary and analysis of the
clinical data
Overview of clinical findings
Important limitations
Evaluation of benefits and risks
based on conclusion.
2.6 Non-clinical summaries
Summary of pharmacokinetic,
pharmacological and toxicology
studies – in-vivo/in-vitro,
species, route and duration
Appropriate age and gender
related effects
2.7 Clinical summaries
Detailed summarization of
the clinical information in
module 5.
Post marketing data for
products that have marketed
in other regions.
Module 3 Quality
Chemical-pharmaceutical information
and biological information
Table of content to direct reviewer
around the document
Provide body of data as follow:
Section S
Section P
Section A
Section R
Section C
Module 4 - 5
Non-clinical and clinical study
reports
Table of content
Location of each study reports
in the CTD
Not indicate the studies
required to support the
application.
Guidance for the industry
• Divided in 4 guidance document
M4Q
MA
CTD
ICH status of harmonization
initiative
5
Implementation
3
2
1
4
ICH guidelines finalized
Consultation outside ICH
Consensus achieved
Technical discussion in EWG
Current status of CTD
Nov, 2000, in San Diego, Step 4 status
Step 4 – Final draft is recommended for
adoption to the regulatory bodies (EU,
Japan and USA)
Modules – additional formatting and
integration of the components of the CTD
May, 2001, Tokyo, a set of principles for
the uniform formatting of the CTD
Oct, 2001, FDA published, eCTD.
eCTD
6 months behind CTD
May, 2001, Tokyo, Step 2 of the
eCTD ICH process was agreed by
M2 EWG.
Specifications developed by ICH M2
EWG
Maintained by eCTD IWG
Electronic submission from applicant
to regulator
M2 EWG – developed change control
process to monitor implementation
process & provide solutions and added
flexibility found necessary during
implementation
Addressed and resolved
- study report structure
- lifecycle management
- consistency with CTD
eCTD specifications are based
on XML technology
New guidance – by USFDA –
for eCTD – for marketing
approval applications (ANDAs,
NDAs, BLAs) + INDs & master
files.
Advantages of CTD
• To save time and resources
• To facilitate regulatory review and
communications
• Appropriate format for the data
• Easy to understand and evaluation of data
• Applicable to all types of products (NCE,
radiopharmaceuticals, vaccines, herbals,
etc.)
Not included in CTD
• No detailed information about content of
dossier
• Which studies/data required for a
successful approval
• Still not identical for all regions (different
regional requirements)
Limitations………
• CTD is only a format, its not a single
dossier with a single content.
• Legal requirements differ in three regions
• ICH guidelines have not yet harmonized in
all requirements
• Pharmacopoeias are not harmonized
• Applicant may have regional preferences.
Benefits……
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Resources savings in building the dossier
Single summaries
Facilitation of regulatory information exchange
Facilitation of response to questions
Harmonized format allowing electronic
transmission
• Partially identical data package
• No actual increase in EU and / or Japanese
application size/review time
Conclusion
• Whilst the realization of the CTD took many
years, there is now a common format for the
submission of Marketing Authorizations
Applications across the three ICH regions Europe, Japan and the USA. This should
facilitate pharmaceutical companies to make
simultaneous filings in the ICH regions as it will
eliminate the extensive work previously required
to convert, for example, a US dossier to an EU
dossier and vice versa.
Questions
• What is CTD?
• Why CTD?
• Write in brief about preparing and
organization of CTD.
• Write in brief about eCTD.
• What are limitations and advantages of
CTD?
References
• www.fda.gov
• www.ich.org
• www.pharmtech.com