Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 1 | Regulatory Requirement on Dossier of Medicinal Products WHO Workshop, October 2007 Sultan Ghani, Director Bureau of Pharmaceutical Sciences Therapeutic Products Directorate, Health Canada
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Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 20071 |
Regulatory Requirement on Dossier of Medicinal Products
WHO Workshop, October 2007
Regulatory Requirement on Dossier of Medicinal Products
WHO Workshop, October 2007
Sultan Ghani, DirectorBureau of Pharmaceutical Sciences
Therapeutic Products Directorate, Health Canada
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 20072 |
OutlineOutline
Common Technical Document (CTD – ICH)
Quality Overall Summary (QOS)
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 20073 |
An Overview of the CTDAn Overview of the CTD
The CTD is not a “Global Dossier” !
It is an agreed-upon common format for the “modular” presentation of summaries, reports and data
Incorporates relevant ICH guidelines
It is organized into five sections: All “modules” harmonized except Module 1 – regional specific
Raw data per regional requirements
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 20074 |
Module 1
Regional Administrative
Information
NonclinicalOverviewQuality
OverallSummary Clinical
Summary
Module 3
Quality
Module 4
NonclinicalStudy Reports
Module 5
ClinicalStudy Reports
ClinicalOverview
NonclinicalSummaries
Not Part of CTD
CTD
Module 2NDS
Result was the CTD Triangle
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 20075 |
CTD StructureCTD Structure
Full dossier contains 5 “Modules” - -
- Only Modules 2-5 are “CTD”
Module 1 – region-specific but always included in complete CTD structure
Module 2- All summaries / overviews
Module 3 – CMC (“Quality”)
Module 4 – Preclinical
Module 5 - Clinical
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 20076 |
Module 2 - CTD SummariesModule 2 - CTD Summaries
2.1 Overall CTD ToC
2.2 CTD 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
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 20077 |
2.2 CTD Introduction2.2 CTD Introduction
General introduction to the pharmaceutical, including Pharmacologic class
Mode of action
Proposed clinical use
Typically 1 page
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 20078 |
Provides factual summary and support for conclusions and critical issues identified in the Clinical Overview
Comparison of results across studies with integration of clinical information
Analysis of all relevant information for dosing recommendations
Typically 50-400 pages (excluding tables)
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 200717 |
2.7 Clinical Summary - Format2.7 Clinical Summary - Format
2.7.1 Summary of biopharmaceutic studies and associated analytical methods
2.7.2 Summary of clinical pharmacology (including clin micro characterization studies)
2.7.3 Summary of clinical efficacy
2.7.4 Summary of clinical safety
2.7.5 References
2.7.6 Synopses of individual studies
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 200718 |
Submission of CMC Information in CTD Format
Submission of CMC Information in CTD Format
3.2.S
3.2.S.1
3.2.S.2
3.2.S.3
3.2.S.4
3.2.S.5
3.2.S.6
3.2.S.7
DRUG SUBSTANCE
General Information
Manufacture
Characterization
Control of Drug Substance
Reference Standards or Materials
Container Closure System
Stability
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 200719 |
Submission of CMC Information in CTD Format (cont’d)
Submission of CMC Information in CTD Format (cont’d)
3.2.P
3.2.P.1
3.2.P.2
3.2.P.3
3.2.P.4
3.2.P.5
3.2.P.6
3.2.P.7
3.2.P.8
DRUG PRODUCT
Description and Composition of the Drug Product
Pharmaceutical Development
Manufacture
Control of Excipients
Control of Drug Product
Reference Standards or Materials
Container Closure System
Stability
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 200720 |
Submission of CMC Information in CTD Format (cont’d)
Submission of CMC Information in CTD Format (cont’d)
3.2.A
3.2.A.1
3.2.A.2
3.2.A.3
3.2.R
APPENDICES
Facilities and Equipment
Adventitious Agents Safety Evaluation
Excipients
REGIONAL INFORMATION
Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 200721 |
Submission of CMC Information in CTD Format
Submission of CMC Information in CTD Format
The CTD Quality Module is unique in that it is a combination of historical development and future commitments that apply to the commercial, post-approval production period.
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Impact of the CTDImpact of the CTD
The ICH CTD represents one of the most ambitious and successful international harmonization activities undertaken
It will significantly reduce time and resources needed by industry to compile applications for global registration
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Benefits of the CTDBenefits of the CTD
More “reviewable” applications
Complete, well-organized submissions
More predictable format
More consistent reviews
Easier analysis across applications
Easier exchange of information
Facilitates electronic submissions
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Is part of a drug submission organized according to ICH’s Common Technical Document (CTD) Guideline (i.e., Module 2.3)
ICH’s CTD-Q structure (including the QOS) has been formally adopted by Canada for various drug submission types, e.g.: Clinical Trial Applications (CTAs)
• Phase I, Phase II/III, BA Studies
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