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SEMINAR ON COMMON TECHNICAL DOCUMENT (CTD)

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Presented By: Payal Santwani Dept. Of 11 PHARMACEUTICS

Contents:

ICH Objectives Introduction To CTD Significance Of CTD Organization Of CTD eCTD References

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ICH M4- COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE:
International Conference on Harmonisation (ICH) was created in 1990.

Agreement between the EU, Japan and the USA to harmonize different regional requirements for registration of pharmaceutical drug products.

A Unique approach because joint effort by regulators and associated pharmaceutical industry trade associations.
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ICH Objectives

Identification and elimination of the need to duplicate studies to meet different regulatory requirements.

More efficient use of resources in the R&D process, as a consequence.

Quicker access for patients to deliver safe and effective new medicines.

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Working Groups

SAFETY QUALITY

EFFICACY

MULTIDISCIPLINARY

STEERING COMMITTEE
Endorses topics, guidelines and monitors 7/13/12 303030 55 progress

BACKGROUND

Through

the

ICH

process,

considerable

harmonization has been achieved among the three regions in the technical requirements for the registration of pharmaceuticals for human use.

However,

until

now, of the

there

has

been of

no the

harmonization

organization

registration documents. Each region has its own requirements for the organization of the technical reports in the submission and for the preparation of the summaries and303030 tables. 7/13/12
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In Japan, the applicants must prepare the GAIYO,

which organizes and presents a summary of the technical information.

In Europe, Expert Reports and tabulated

summaries are required, and written summaries are recommended.

The U.S. FDA has guidance regarding the format To avoid the need to generate and compile

and content of the New Drug Application.

different registration dossiers, this guideline describes a format for the Common Technical
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Document that will be acceptable in all three

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Regulatory Communication

ICH

has

sought

to

enhance

regulatory

communication through the development of:

Standardized data elements, example: E2B Controlled vocabularies, example: MedDRA Common format for drug registration: CTD Electronic specifications and standards for the transmission
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of

such

information,
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example: ESTRI and eCTD

Regulatory Communication

Benefits:

Speak

same

language:

promotes

communication

Quality,

accuracy

and

consistency

of

information

Improve

timeliness

of

communications

(electronic transmission)

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CTD/eCTD reduces delays and costs associated


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ORIGIN OF CTD

ICH
EWG
WAS OFFICIALLY SIGNED OFF IN NOVEMBER 2000,

CTD

AT 5TH ICH CONFERENCE; SAN DIEGO,CALIFORNIA.

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CTD

WHAT IS IT?

IT IS :

A common harmonized FORMAT for applications for preparing marketing authorizations in the three ICH regions. A TEMPLATE for presenting data in the dossier.
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IT IS NOT:
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CTD

CTD IS A JOINT EFFORT OF 3 REGULATORY AGENCIES: 1.European Medicines Agency (EMEA, Europe), 2. Food and Drug Administration (FDA, USA) and 3. Ministry of Health, Labour and Welfare (MHLW,Japan). It has been adopted by several other

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countries including Canada and Switzerland. 303030 1212

Any guideline which is given by ICH passes through different steps. These different steps are called STATUS of that GUIDELINE.
FUNCTIONALITY Development of Consensus Text released for consultation Consultation outside ICH ICH guideline finalized Implementation Status of CTD STEP 4 STATUS ACHIEVED IN NOV.2000 IN 5TH ICH CONFERENCE IN STEP 5 STATUS SANDIEGO.. ACHIEVED IN MAY.2001 IN ICH MEETING IN TOKYO. GUIDANCE MADE AVAILABLE TO INDUSTRY IN OCTOBER 16,2001 BY FDA.
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STAT US Step 1 Step 2 Step 3 Step 4 Step 5

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SIGNIFICANCE OF CTD
Avoid generating and compiling different registration dossiers Common format will significantly reduce the time and resources Facilitates simultaneous submission in three regions Facilitates exchange of information among regulatory authorities Faster availability of new medicines
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Ease the preparation of electronic submissions


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STRUCTURE OF CTD:
Divided into various modules having different contents

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The CTD Triangle


Regional Admin Informatio n

NOT Part of the CTD

Module 1 Module 2
Nonclinical Overview Quality Overall Summary Nonclinical Summary Clinical Overview Clinical Summary Clinical Study Reports

The CTD

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Module 3

Qualit y

Nonclinical Study Reports

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Module 4

Module 5

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May 2001 Steering Committee

Numbering System
1.0 Regional Administrative Information 1.1 ToC of Module 1 or overall ToC, Module including Module 1 1 1. 2.1 ToC of the CTD (Mod 0 2,3,4,5) 2.2 Introduction 2. 1 2.3 Quality Overall 2. Summary 2 2.4 Nonclinical 2. 2. Overview 2.5 Clinical 5 4 Overview 2. 2. 2.6 Nonclinical 6 7 Summary 2.7 Clinical Module Module 4 Nonclinica 5Clinical Summary Study l Reports Study 303030 1717 5.0

Module 2 2. 3 Module 3 Qualit y 3.0 7/13/12

The CTD should be organized according to the following general outline


Module 1: Administrative Information and

Prescribing Information

1.1 Table of Contents of the Submission Including Module 1

1.2 Documents Specific to Each Region (for example,


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application
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forms,

prescribing
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information)

Module 2: Common Technical Document Summaries 2.1 CTD Table of Contents 2.2 CTD Introduction 2.3 Quality Overall Summary 2.4 Nonclinical Overview 2.5 Clinical Overview 2.6 Nonclinical Written and Tabulated Summary Pharmacology Pharmacokinetics Toxicology 2.7 Clinical Summary Biopharmaceutics and Associated Analytical Methods Clinical Pharmacology Studies Clinical Efficacy Clinical Safety 303030 7/13/12 1919 Synopses of Individual Studies

Module 3: Quality 3.1 Module 3 Table of Contents 3.2 Body of Data 3.3 Literature References Module 4: Nonclinical Study Reports 4.1 Module 4 Table of Contents 4.2 Study Reports 4.3 Literature References Module 5: Clinical Study Reports 5.1 Module 5 Table of Contents 5.2 Tabular Listing of All Clinical Studies 5.3 Clinical Study Reports 5.4 Literature References
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The sequence of M4 Common Technical Document for the Registration of Pharmaceuticals for Human Use is:

M4 Document

Organization of the Common Technical

M4 Quality - Quality overall summary and CTD Quality M4 Safety - Nonclinical Summaries and
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Organization and Format of the ICH Guidance for

Industry
Although the CTD is organized by modules, the guidance for industry that provide recommendations for applicants on preparing the CTD have been organized by topic: Quality, Safety, and Efficacy. As a result, guidance discussing Module 2 is divided among three guidance.

Guidance on the Quality section of the CTD (Module 2,

Quality Overall Summary (QOS), and Module 3) can be found in the guidance for industry M4Q: The CTD Quality.

Guidance on the Safety section of the CTD (Module 2, the

Nonclinical Overview and the Nonclinical Written and Tabulated Summaries, and Module 4) can be found in the guidance for industry M4S: The CTD Safety.
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GENERAL PRINCIPLES
Throughout the Common Technical Document, the display of information should be unambiguous and transparent, in order to facilitate the review of the basic data and to help a reviewer become quickly oriented to the application contents. Text and tables should be prepared using margins that allow the document to be printed on both A4 paper (E.U. and Japan) and

8.5 x 11 paper (U.S.). The left-hand margin should be sufficiently large that information is not obscured by the method of binding.

Font sizes for text and tables should be of a style and size that are large enough to be easily legible, even after photocopying.

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eCTD

Six months behind CTD, the eCTD was a transport format to be moved into an agencys review environment.

Electronic Common Technical Document (e-CTD) submission protocol is designed by the ICH to facilitate regulatory submissions to US, EU and Japan, in electronic format.

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e-CTD issues.

as

methodology

of

regulatory

document

transmission has been conceived to address two major

One to solve the issue of managing colossal paper documentation at the receiving end (i.e. USFDA, EMEA) & other to solve the major issue of managing the life-cycle of the drug approval documentation." This will automatically improve the throughput of the approval process at the FDA, which logically should also result in improved approval cycle timelines.

Biggest Payoff-To eliminate controversy of A4 vs. 8


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Paper CTD

1 oc D c2 Do 3 oc D c4 Do

eCT D
File 1 File 2

File 3

File 4

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eCTD: electronic CTD


-

Developed by M2 EWG (Multidisciplinary 2 Expert Working Group) of ICH. Industry <-----> Message <------> Agency Paper submission has been replaced by electronic submission

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Characteristics of eCTD:1. Files Referenced in the XML Backbone(s) (Extensible Markup Language) REASONS: 1. It manages the large data for the entire submission and for each document within the submission. 2. This 303030 backbone allows the eCTD XML 2828

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2.The file formats that can be included in the eCTD are Portable Document Format (PDF) and XML. However other formats can be used for graphs and images. JPEG PNG GIF
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3. All eCTD Submissions Include Module 1


Module 1 Identifies following important information:

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Company Name
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Nomenclature for files and eCTD submission.


EXAMPLE :- MODULE 2 FILE NOMENCLATURE AND eCTD submission
Description 2.2 introduction 2.3 Quality overall summary 2.4 Non clinical Overview 2.5 Clinical Overview 2.6 Non clinical Written and Tabulated Summaries 2.7 Clinical summary File Name 22-intro 23-qos 24-nonclin-over 25-clin-over 26-nonclin-sum

27-clin-sum

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Agency Sites with eCTD submission Information


FDA : http://www.fda.gov/cder/regulatory/ersr/ectd.htm EMEA(EU) : http://esubmission.eudra.org/ MHLW(JP) : http://www.mhlw.go.jp/english/index.html

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Summary

CTD was introduced with the aim to harmonize submission of technical data for registration of human use in different regions. The CTD is not a Global Dossier!

Content different for US, EU and Japan based on individual regulations , Some regulations never covered in ICH. It is an agreed upon common format for the modular presentation of summaries, reports and data. After 10 years of implementation of CTD, we can say that considerable harmonization has been achieved in various regions for submission of technical data.
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REFERENCES:

www.ich.org http://www.fda.gov/cder/regulatory/ersr/ectd.htm http://esubmission.eudra.org/ http://www.fda.gov/cder/guidance/index.htm European Medicines CPMP/ICH/2887/99 Agency; February 2004;

Guidance For Industry On Preparation Of Common Technical Document For Import / Manufacture And Marketing Approval Of New Drugs For Human Use; Central Drugs 303030 Standard Control Organization; 7/13/12 3434

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