Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual (Good Drug Development Series, Vol 1)

good Drug Regulatory Practices Offers A Series Of Policies And Procedures To Assure Quality And Timely Regulatory Submissions To National Regulatory Agencies. This Book Begins With Introductory Chapters Describing The Need For Policy Documentation, And The Philosophy Underlying The Policies, And Presents Policies And Standards That Can Be Used As Presented Or Adapted To Individual Situations In Your Company. Contents......Page 3 Foreword......Page 8 Preface......Page 10 Acknowledgments......Page 11 Introduction......Page 12 Part I: THE REGULATORY AFFAIRS QUALITY SYSTEM......Page 13 Why Regulatory Affairs? The Development of Drug Laws and Drug Regulations......Page 14 Regulatory Affairs: Development in the Pharmaceutical Industry......Page 22 Regulatory Affairs Professional Societies......Page 23 Good Practice and Quality Management: An Overview......Page 26 References......Page 30 Good Regulatory Practice: A Proposal for a Quality System......Page 33 Good Regulatory Practice: A Proposal for a Quality System for Regulatory Bodies......Page 36 Good Regulatory Practice: The Role of Regulatory Affairs in Product Development......Page 39 References......Page 45 3. Check Your Quality System......Page 46 Quality System Questionnaire......Page 47 Conclusions from This Test......Page 53 Part II: THE REGULATORY AFFAIRS QUALITY MANUAL......Page 54 Introduction......Page 55 Regulatory Affairs Quality Policy......Page 57 The Quality System's Outline......Page 60 Notes......Page 61 Appendix: Numbers and Titles of Policies and Standards in This Manual......Page 63 5. The Philosophy Behind the Policies......Page 65 Policy 02: The Policy on Auditing and Compliance......Page 66 Policy 03: The Policy on Application for Clinical Trial License......Page 69 Policy 04: The Policy on Application for Marketing Authorization......Page 71 Policy 05: The Policy on Archiving Management......Page 87 Policy 06: The Policy on Change Alert/Authorization Process......Page 90 Policy 07: The Policy on Contact Report......Page 92 Policy 08: The Policy on Contact with Regulatory Body......Page 93 Policy 09: The Policy on Crisis Management......Page 94 Policy 10: The Policy on Documents for Regulatory Purposes......Page 97 Policy 11: The Policy on Dossier......Page 102 Policy 12: The Policy on Education/Training......Page 108 Policy 13: The Policy on Electronic Submission......Page 115 Policy 14: The Policy on Environmental Protection......Page 126 Policy 15: The Policy on Global Dossier......Page 132 Policy 16: The Policy on Import/Export......Page 138 Policy 17: The Policy on Information Management......Page 139 Policy 19: The Policy on Inspection......Page 145 Policy 20: The Policy on Labeling......Page 148 Policy 21: The Policy on Outsourcing......Page 151 Policy 22: The Policy on Periodic Safety Update Report......Page 152 Policy 24: The Policy on Promotion/Advertising Compliance......Page 153 Policy 25: The Policy on Regulations and Guidelines......Page 154 Policy 26: The Policy on Regulatory Strategy......Page 158 Policy 27: The Policy on Submission......Page 162 Policy 28: The Policy on Terminology......Page 167 Policy 29: The Policy on Tools......Page 170 6. Policies......Page 172 01: The Policy on Policy......Page 173 02: The Policy on Auditing and Compliance......Page 181 03: The Policy on Application for Clinical Trial License......Page 187 04: The Policy on Application for Marketing Authorization......Page 190 05: The Policy on Archiving Management......Page 193 06: The Policy on Change Alert/Authorization Process......Page 197 07: The Policy on Contact Report......Page 202 08: The Policy on Contact with Regulatory Body......Page 205 09: The Policy on Crisis Management......Page 209 10: The Policy on Documents for Regulatory Purposes......Page 213 11: The Policy on Dossier......Page 217 12: The Policy on Education/Training......Page 221 13: The Policy on Electronic Submission......Page 227 14: The Policy on Environmental Protection......Page 230 15: The Policy on Global Dossier......Page 234 16: The Policy on Import/Export......Page 238 17: The Policy on Information Management......Page 241 18: The Policy on Information Technology......Page 247 19: The Policy on Inspection......Page 252 20: The Policy on Labeling......Page 255 21: The Policy on Outsourcing......Page 258 22: The Policy on Periodic Safety Update Report......Page 261 23: The Policy on Project Assignments......Page 264 24: The Policy on Promotion/Advertising Compliance......Page 267 25: The Policy on Regulations and Guidelines......Page 270 26: The Policy on Regulatory Strategy......Page 275 27: The Policy on Submission......Page 278 28: The Policy on Terminology......Page 282 29: The Policy on Tools......Page 285 7. Standards......Page 288 01.01: A Standard for Policy......Page 289 01.02: A Standard for Standard Operating Procedure......Page 292 03.01: A Standard for U.S. Application for Clinical Trial License: IND Content and Format......Page 295 04.01: A Standard for EU Application for Marketing Authorization: Chemical Active Substances......Page 300 04.02: A Standard for EU Application for Marketing Authorization: Biologicals, Part II......Page 309 04.03: A Standard for U.S. Application for Marketing Authorization......Page 319 07.01: A Standard for Regulatory Body Contact Report......Page 326 10.01: A Standard for Regulatory Document Types......Page 328 11.01: A Standard for Dossier......Page 331 15.01: A Standard for Global Dossier......Page 337 20.01: A Standard for Labeling......Page 382 27.01: A Standard for Submission......Page 384 28.01: A Standard for Terminology......Page 388 Glossary......Page 402 C......Page 426 D......Page 427 E......Page 428 I......Page 429 M......Page 430 Q......Page 431 S......Page 432 W......Page 433 This book attempts to be the first systematic treatment on what should now be named Good Drug Regulatory Practice (GDRP). It covers regulatory affairs regarding global product development for the European Union, Japan, and the United States. For an understanding of drug laws worldwide, some basic facts must be understood and borne in mind.