Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual

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