Regulatory Affairs Professionals Society 479 Index Major discussions of a topic are indicated by page numbers given in bold typeface. In each chapter, tables and figures are indicated by page number with “t” or “f” and the number of the table or figure following, with the chapter number omitted. In chapter 5, Figure 5-1 on page 54 will appear as 54f1. The index includes only countries where there has been substantive information within the text a listing of country names (e.g., organizational membership) or other parenthetical listing without additional informa- tion in the text will not be found in the index. Country names found only in tables or figures are not included in the index, although both tables and figures are indexed. A ACSS Consortium, 92 active implantable medical devices (AIMDs), 231–239 Canadian regulation for, 238 country-specific regulatory requirements Australia, 237 Brazil, 238 EU, 236–237 US, 237–238 definitions and examples, 232–233 general considerations, 233 regulatory approval principles device description, 235 labeling, 235–236 manufacturing process validation, 236 risk analysis/control, 236 verification/validation, 236 safety considerations, 234–235 Active Pharmaceutical Ingredients (APIs) ASEAN MRAs, 134 batch verification process, 143 botanical drug products (BDPs), 411 botanical products, 411–412 EDQM inspections, 124 EU MRAs, 128 FDA inspections, 122 non-EU sources, 71 vaccines, 324 See also drug product drug substance Active Substance Master File (ASMF), 264, 268 Adequate Intake (AI), 386 adjuvants. See vaccines Administración Nacional de Medicamentos, Alimentos y Tec- nología Médica (ANMAT). See National Administration of Medicines, Food and Medical Technology Adriatic region. See Southern and Eastern Europe Advanced Therapy Medicinal Products (ATMPs), 371–384 approved autologous products, 375t1 cell therapy medicinal products, 373 challenges/way forward, 382–383, 383f5 EU regulations approval centers, 377f4 framework for, 376t2, 378t3, 379t4 guidelines, 381t6 pathway, 377, 378t3, 378t4 gene therapy medicinal products, 373 indications for therapy trials of, 374f2 Japanese regulations approval centers, 377f4 framework for, 376t2 pathways, 382 process development, 374–375, 376f3 product types, 372–373 sources and manufacturing, 373f1
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