ix Regulatory Writing: An Overview
Figures
Figure 6-1. Example Template Guide to Preparing Planning and Strategy Document for Regulatory
Submission.................................................................................................................................48
Figure 6-2. Example SOP Template.............................................................................................................52
Figure 6-3. Example Template Flow Diagram. ............................................................................................53
Figure 6-4. Example Template of Work Instruction.....................................................................................54
Figure 7-1. Initial Marketing Authorisation Application Through the Centralised Procedure.....................68
Figure 11-1. Flowchart for Developing CSRs..............................................................................................103
Figure 16-1. Labeling Examples...................................................................................................................152
Figure 18-1. Example of Agency Deficiency Communication. ....................................................................175
Figure 22-1. Stepwise Process for Biosimilarity Demonstration...................................................................207
Figure 26-1. Advances in the Discovery and Development of Orphan Drugs Over the Past
Four Decades. ..........................................................................................................................250
Figure 26-2. China National Medical Products Administration (NMPA) Emergency Approval
Process and Timeline for Drug Products ................................................................................251
Figure 29-1. Example of a Lay Summary for Children. ...............................................................................273
Tables
Table 1-1. Definitions of Medical Writer. .....................................................................................................2
Table 1-2. Summary of Prescription Drug User Fee Act (PDUFA) and its Reauthorizations. .....................8
Table 4-1. Overview of Selected FDA COVID-19-Related Guidance Documents. ..................................32
Table 4-2. Regulatory Requirements for Medical Devices ..........................................................................33
Table 4-3. Overview of ICH Quality Guidelines. .......................................................................................34
Table 4-4. Overview of ICH Safety Guidelines. .........................................................................................36
Table 4-5. Overview of ICH Efficacy Guidelines........................................................................................37
Table 4-6. Overview of ICH Multidisciplinary Guidelines.........................................................................39
Table 7-1. Review Milestones......................................................................................................................61
Table 7-2. Timetable for Evaluation of the MAA via the Centralised Procedure. ......................................66
Table 9-1. Selected Historical Events in Human Experimentation.............................................................80
Table 9-2. Essential Informed Consent Form Elements.............................................................................81
Table 9-3. Additional Informed Consent Form Elements...........................................................................82
Table 9-4. Examples of Lay Language.........................................................................................................84
Table 9-5. Sample GDPR Privacy Notice Elements for Informed Consent Form......................................86
Table 10-1. Guidelines Specifically Referenced in ICH Statistical Principles for Clinical Trials E9............92
Table 11-1. Guidance Documents for CSRs. ..............................................................................................100
Table 11-2. Common Terminology for CSRs..............................................................................................101
Table 12-1. Example Template of Section 3.2.P.3 Manufacture and 3.2.P.3.1 Manufacturer(s)..................112
Table 13-1. US FDA Nonclinical Testing Guidance Documents................................................................116
Table 13-2. Content Areas of the Three Nonclinical Written Summaries ..................................................119
Table 14-1. Documents That May Contain an Integrated Discussion of Clinical Data. .............................130
Table 14-2. Clinical Overview Goals...........................................................................................................132
Table 14-3. Clinical Overview Text Sections as Described in ICH M4E With Brief Explanations. ..........133
Table 14-4. Summary of New Guidance on Clinical Overview Section 2.5.6 Benefit-Risk
Conclusions (Text Sections). ....................................................................................................135
Table 14-5. Clinical Summary Text Subsections. ........................................................................................136
Table 14-6. ICH M4E Table Templates for Clinical Summary Subsections...............................................137
Table 14-7. ICH E2C Contents of the Periodic Safety Update Report. .....................................................141
Table 15-1. Investigator’s Brochure Contents Specified in ICH E6, Section 7. ..........................................147
Figures
Figure 6-1. Example Template Guide to Preparing Planning and Strategy Document for Regulatory
Submission.................................................................................................................................48
Figure 6-2. Example SOP Template.............................................................................................................52
Figure 6-3. Example Template Flow Diagram. ............................................................................................53
Figure 6-4. Example Template of Work Instruction.....................................................................................54
Figure 7-1. Initial Marketing Authorisation Application Through the Centralised Procedure.....................68
Figure 11-1. Flowchart for Developing CSRs..............................................................................................103
Figure 16-1. Labeling Examples...................................................................................................................152
Figure 18-1. Example of Agency Deficiency Communication. ....................................................................175
Figure 22-1. Stepwise Process for Biosimilarity Demonstration...................................................................207
Figure 26-1. Advances in the Discovery and Development of Orphan Drugs Over the Past
Four Decades. ..........................................................................................................................250
Figure 26-2. China National Medical Products Administration (NMPA) Emergency Approval
Process and Timeline for Drug Products ................................................................................251
Figure 29-1. Example of a Lay Summary for Children. ...............................................................................273
Tables
Table 1-1. Definitions of Medical Writer. .....................................................................................................2
Table 1-2. Summary of Prescription Drug User Fee Act (PDUFA) and its Reauthorizations. .....................8
Table 4-1. Overview of Selected FDA COVID-19-Related Guidance Documents. ..................................32
Table 4-2. Regulatory Requirements for Medical Devices ..........................................................................33
Table 4-3. Overview of ICH Quality Guidelines. .......................................................................................34
Table 4-4. Overview of ICH Safety Guidelines. .........................................................................................36
Table 4-5. Overview of ICH Efficacy Guidelines........................................................................................37
Table 4-6. Overview of ICH Multidisciplinary Guidelines.........................................................................39
Table 7-1. Review Milestones......................................................................................................................61
Table 7-2. Timetable for Evaluation of the MAA via the Centralised Procedure. ......................................66
Table 9-1. Selected Historical Events in Human Experimentation.............................................................80
Table 9-2. Essential Informed Consent Form Elements.............................................................................81
Table 9-3. Additional Informed Consent Form Elements...........................................................................82
Table 9-4. Examples of Lay Language.........................................................................................................84
Table 9-5. Sample GDPR Privacy Notice Elements for Informed Consent Form......................................86
Table 10-1. Guidelines Specifically Referenced in ICH Statistical Principles for Clinical Trials E9............92
Table 11-1. Guidance Documents for CSRs. ..............................................................................................100
Table 11-2. Common Terminology for CSRs..............................................................................................101
Table 12-1. Example Template of Section 3.2.P.3 Manufacture and 3.2.P.3.1 Manufacturer(s)..................112
Table 13-1. US FDA Nonclinical Testing Guidance Documents................................................................116
Table 13-2. Content Areas of the Three Nonclinical Written Summaries ..................................................119
Table 14-1. Documents That May Contain an Integrated Discussion of Clinical Data. .............................130
Table 14-2. Clinical Overview Goals...........................................................................................................132
Table 14-3. Clinical Overview Text Sections as Described in ICH M4E With Brief Explanations. ..........133
Table 14-4. Summary of New Guidance on Clinical Overview Section 2.5.6 Benefit-Risk
Conclusions (Text Sections). ....................................................................................................135
Table 14-5. Clinical Summary Text Subsections. ........................................................................................136
Table 14-6. ICH M4E Table Templates for Clinical Summary Subsections...............................................137
Table 14-7. ICH E2C Contents of the Periodic Safety Update Report. .....................................................141
Table 15-1. Investigator’s Brochure Contents Specified in ICH E6, Section 7. ..........................................147