Common Technical Document

COMMON TECHNICAL DOCUMENT , its granularities, benefits, advantages, shortcomings.

1. Common Technical Document (CTD) BINDU KSHTRIYA

2. CONTENT 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

3. What is CTD? Internationally accepted 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).

4. 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.

5. To facilitate simultaneous submission in three regions. To facilitate exchange of regulatory information. Faster availability of new medicines

6. Preparing & Organization of CTD It is organized into:- Module 2: CTD summaries Module 3: Quality Module 4: Nonclinical reports Module 5: Clinical reports

7. The CTD Triangle

8. Module 1. Administrative information and prescribing information. Document specific to each region. E.g. Application form Proposed label for use in the region

9. 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

10. 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.

11. 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.

12. 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.

13. 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

14. 2.7 Clinical summaries Detailed summarization of the clinical information in module 5. Post marketing data for products that have marketed in other regions.

15. Module 3 Quality Chemical-pharmaceutical information and biological information Table of content to direct reviewer around the document Provide body of data as follow:

16. 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.

17. 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.

18. 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.)

19. 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)

20. Shortcomings of CTD 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 .

21. Benefits of CTD 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

22. 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.

23. Thank you Bindu Kshtriya