1. 1 COMMON TECHNICAL DOCUMENT / 19

2. 2 ORIGIN OF CTD… ICH EWG CTD WAS OFFICIALLY SIGNED OFF IN NOVEMBER 2000, AT 5 TH ICH CONFERENCE; SAN DIEGO,CALIFORNIA. / 19

3. 3 CTD CTD IS A JOINT EFFORT OF 3 REGULATORY AGENCIES: 1.European Medicines Agency (EMEA, Europe),European Medicines AgencyEurope 2. Food and Drug Administration (FDA, USA) andFood and Drug AdministrationUSA 3. Ministry of Health, Labour and Welfare (MHLW,Japan).Ministry of Health, Labour and Welfare It has been adopted by several other countries including Canada and Switzerland. CTD is maintained by ICH through EWG. / 19

4. 4  Any guideline which is given by ICH passes through different steps.  These different steps are called STATUS of that GUIDELINE. Step 1 Step 2 Step 3 Step 4 Step 5 STATUS Development of Consensus Text released for consultation Consultation outside ICH ICH guideline finalized Implementation FUNCTIONALITY Status of CTD STEP 4 STATUS ACHIEVED IN NOV.2000 IN 5 TH ICH CONFERENCE IN SANDIEGO.. STEP 5 STATUS ACHIEVED IN MAY.2001 IN ICH MEETING IN TOKYO. GUIDANCE MADE AVAILABLE TO INDUSTRY IN OCTOBER 16,2001 BY FDA. / 19

5. 5 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. / 19

6. 6 STRUCTURE OF CTD: - Divided into various modules having different contents. / 19

7. 7 MODULE 1 1.REGIONAL INFO. 1.1 ToC NOT A PART OF CTD 2.1 CTD ToC 2.2 CTD INTRODUCTION 2.3 QOS 2.4 NCO 2.6 NCWTS 2.5CO 2.7 CWTS MODULE 3 3Quality 3.1 ToC MODULE 4 4 non clinical study reports 4.1 ToC MODULE 5 5 clinical study reports 5.1 ToC MODULE 2 PARTS OF CTD / 19 Max.40 or 80 pgs. Max. 30 pgs. Max. 30 100 - 150 pgs. 50 - 400 pgs.

8. 8 Paper CTD Doc 4 Doc 3 Doc 2 Doc 1 eCTD File 1File 2 File 3File 4 / 19

9. 9 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 Industry Message Agency Paper submission has been replaced by electronic submission / 19

10. 10 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 XML backbone allows the eCTD submission to be viewed via a web browser and can be loaded on a Web server. / 19

11. 11 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 -may be used for higher resolution. / 19

12. 12 3. All eCTD Submissions Include Module 1 Module 1 Identifies following important information:  Company Name  Drug Name  Submission Type  Submission Date  Application Number  Sequence Number / 19

13. 13 Nomenclature for files and eCTD submission. DescriptionFile Name 2.2 introduction22-intro 2.3 Quality overall summary23-qos 2.4 Non clinical Overview24-nonclin-over 2.5 Clinical Overview25-clin-over 2.6 Non clinical Written and Tabulated Summaries 26-nonclin-sum 2.7 Clinical summary27-clin-sum EXAMPLE:- MODULE 2 FILE NOMENCLATURE AND eCTD submission / 19

14. 14 Agency Sites with eCTD submission Information FDA : http://www.fda.gov/cder/regulatory/ersr/ectd.htmhttp://www.fda.gov/cder/regulatory/ersr/ectd.htm EMEA(EU) : http://esubmission.eudra.org/http://esubmission.eudra.org/ MHLW(JP) : http://www.mhlw.go.jp/english/index.htmlhttp://www.mhlw.go.jp/english/index.html / 19

15. 15 Summary CTD was introduced with the aim to harmonize submission of technical data for registration of human use in different regions. After 5 years of implementation of ctd,we can say that considerable harmonization has been achieved in various regions for submission of technical data. More and more regulatory agencies have started association with this implementation generated actually by ICH before 5 years back. / 19

16. 16 FOR EXAMPLE : TGA (AUSTRALIAN REGULATORY AGENCY) has started submission of technical data in the form of CTD. http://www.tga.gov.au/docs/html/eugctd.htm http://www.tga.gov.au/docs/pdf/euguide/tgamod1.pdf http://www.tga.gov.au/docs/pdf/euguide/ich/ctdm2quality.pdf http://www.tga.gov.au/docs/pdf/euguide/ich/ctdm2safety.pdf http://www.tga.gov.au/docs/pdf/euguide/ich/ctdm2efficacy.pdf AND TGA IS NOW WORKING ON A PROJECT TO IMPLEMENT eCTD for marketing authorization, NDA, ANDA AND DIFFERENT DOSSIER SUBMISSION. / 19

17. 17 Study questions: 1.What is CTD? What are the advantages of it? (uni. exam…2005) 2.COMMENT ON:‘CTD is a common guideline for WHO,ICH,MCA,EMEA & USFDA.’ (uni.exam…2006) 3. What is CTD? Why it is introduced? Who regulates it? Give diagrammatic representation, advantages and exclusions of it. (uni. exam…2007) / 19

18. 18 REFERENCES:- www.ich.org http://www.fda.gov/cder/regulatory/ersr/ectd.htm http://esubmission.eudra.org/ http://www.mhlw.go.jp/english/index.html http://www.tga.gov.au/docs/html/eugctd.htm / 19

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