A Guide on the Preparation of a Common Technical Document

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GUIDELINES ON COMMON TECHNICAL DOCUMENT (CTD)

28.10.2010

GUIDANCE FOR INDUSTRY ON PREPARATION OF COMMON TECHNICAL DOCUMENT FOR IMPORT / MANUFACTURE AND MARKETING APPROVAL OF NEW DRUGS FOR HUMAN USE (NEW DRUG APPLICATION – NDA) DRAFT GUIDANCE This guidance documents is for feedback purpose only Comments and suggestion on this document should be submitted within 60 days of publication to CDSCO, FDA Bhavan Kotla Road, New Delhi – 110002

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH & FAMILY WELFARE GOVT. OF INDIA, NOVEMBER 2010

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GUIDELINES ON COMMON TECHNICAL DOCUMENT (CTD)

28.10.2010

1 ABBREVIATIONS
API BA BE CD CDSCO CPP CTD FSC GMP ICH ICMJE INR iv MA NDA NRA OCR PD PK po QOS WHO Active Pharmaceutical Ingredient Bioavailability Bioequivalence Compact Disc Central Drugs Standard Control Organization Certificate of Pharmaceutical Product Common Technical Document Free Sale Certificate Good Manufacturing Practices International Conference on Harmonisation International Committee of Medical Journal Editors Indian National Rupee intravenous Market Authorization New Drug Application National Regulatory Authority Optical Character Recognition Pharmacodynamics Pharmacokinetics per oral Quality Overall Summary World Health Organization

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GUIDELINES ON COMMON TECHNICAL DOCUMENT (CTD)

28.10.2010

2 TABLE OF CONTENTS
1 2 3 4 5 ABBREVIATIONS ...................................................................................... 2 TABLE OF CONTENTS .............................................................................. 3 BACKGROUND ......................................................................................... 4 SCOPE ..................................................................................................... 6 GENERAL CONSIDERATIONS ................................................................... 7 5.1 6 FURTHER CLARIFICATIONS .............................................................. 11

GUIDELINES FOR PREPARATION OF CTD.............................................. 13 6.1 6.2 6.3 6.4 6.5 6.6 CTD: OVERVIEW ............................................................................... 13 MODULE 1: GENERAL INFORMATION .............................................. 15 MODULE 2: CTD SUMMARIES .......................................................... 20 MODULE 3: QUALITY ........................................................................ 76 MODULE 4: NON-CLINICAL STUDY REPORTS................................... 94 MODULE 5: CLINICAL STUDY REPORTS ........................................... 97

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ANNEXURES ........................................................................................ 106 7.1 7.2 7.3 ANNEXURE I: DIAGRAMMATIC REPRESENTATION OF CTD ............ 106 ANNEXURE II: FORMAT FOR UNDERTAKING OR DECLARATION .... 107 ANNEXURE III: FORMAT FOR LISTING OF CLINICAL STUDIES ....... 110

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GUIDELINES ON COMMON TECHNICAL DOCUMENT (CTD)
GUIDANCE FOR INDUSTRY

28.10.2010

ON PREPARATION OF COMMON TECHNICAL DOCUMENT FOR IMPORT / MANUFACTURE AND MARKETING APPROVAL OF DRUGS FOR HUMAN USE (NEW DRUG APPLICATION - NDA)

3 BACKGROUND
Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing of new drug by the applicant by Central Drugs Standard Control Organization (CDSCO). The regulations under Drugs and Cosmetics Rules 122A, 122B and 122D and further Appendix I, IA and VI of Schedule Y, describe the information required for approval of an application to import or manufacture of new drug for marketing. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Till date, applicants have used many different approaches in organizing the information and the differences in organization of data in each...
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