A Guide on the Preparation of a Common Technical Document
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DRAFT GUIDANCE This guidance documents is for feedback purpose only Comments and suggestion on this document should be submitted within 60 days of publication to CDSCO, FDA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
Page 1 of 110
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
Page 2 of 110
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
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DRAFT GUIDANCE This guidance documents is for feedback purpose only Comments and suggestion on this document should be submitted within 60 days of publication to CDSCO, FDA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
Page 1 of 110
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
Page 2 of 110
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