Regulation of Regenerative Medicines: A Global Perspective
vi
Table 14-3. Overview of Postapproval Change Classifications, Reporting Categories, and
Timelines. .........................................................................................................................173
Table 15-1. TGA Target Timeframes for TGA Review Pathways......................................................179
Table 15-2. Classes of Biologicals in Australia.....................................................................................180
Table 15-3. Standards for Biologicals in Australia. ..............................................................................181
Table 15-4. Cellular Therapies Listed on the ARTG...........................................................................182
Table 15-5. Facilitated Review Pathways for Prescription Medicines in Australia...............................184
Table 15-6. Gene Therapy Prescription Medicines Listed on the ARTG............................................186
Table 15-7. Cell and Gene Therapy Product Licenses From OGTR...................................................186
Table 16-1. Classification of Class 1 and Class 2 CTGTP. .................................................................192
Table 16-2. NDA Application Routes and Conditions for a Class 2 CTGTP. ...................................193
Table 16-3. Dossier Requirements for a New Class 2 CTGTP Application. ......................................194
Table 16-4. Application Turnaround Time in Working Days. .............................................................197
Table 16-5. Reporting Timelines for Serious Adverse Events..............................................................198
Table 16-6. Differences Between a CTA and a CTN. .........................................................................199
Table 16-7. Supporting Documents for Submission in CTA and CTN Applications.........................201
Abbreviations and Acronyms. ................................................................................................................209
Glossary..................................................................................................................................................215
Index......................................................................................................................................................221
vi
Table 14-3. Overview of Postapproval Change Classifications, Reporting Categories, and
Timelines. .........................................................................................................................173
Table 15-1. TGA Target Timeframes for TGA Review Pathways......................................................179
Table 15-2. Classes of Biologicals in Australia.....................................................................................180
Table 15-3. Standards for Biologicals in Australia. ..............................................................................181
Table 15-4. Cellular Therapies Listed on the ARTG...........................................................................182
Table 15-5. Facilitated Review Pathways for Prescription Medicines in Australia...............................184
Table 15-6. Gene Therapy Prescription Medicines Listed on the ARTG............................................186
Table 15-7. Cell and Gene Therapy Product Licenses From OGTR...................................................186
Table 16-1. Classification of Class 1 and Class 2 CTGTP. .................................................................192
Table 16-2. NDA Application Routes and Conditions for a Class 2 CTGTP. ...................................193
Table 16-3. Dossier Requirements for a New Class 2 CTGTP Application. ......................................194
Table 16-4. Application Turnaround Time in Working Days. .............................................................197
Table 16-5. Reporting Timelines for Serious Adverse Events..............................................................198
Table 16-6. Differences Between a CTA and a CTN. .........................................................................199
Table 16-7. Supporting Documents for Submission in CTA and CTN Applications.........................201
Abbreviations and Acronyms. ................................................................................................................209
Glossary..................................................................................................................................................215
Index......................................................................................................................................................221