Regulatory Affairs Professionals Society 271 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 mem- bership) or other parenthetical listing without additional information 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, 30 Active Pharmaceutical Ingredients (APIs) batch verification process, 81 vaccines, 174 Active Substance Master File (ASMF), 114, 118 Advanced Therapy Medicinal Products (ATMPs), thera- peutic vaccines, 175 Adverse Drug Reaction (ADR) definition, 6 Adverse Event (AE) definition, 6–7, 107 adverse event reporting Canada, 193 postmarket surveillance, 91–92 traceability requirements, 185 advertising and promotion, 13–19 de facto DTC, 17 definitions and types, 15 direct-to-consumer (DTC), 17 free samples in, 18 freedom of speech, 14 harmonization of, 14–15 Health Action International, 16 healthcare product regulation, 15 homeopathic products, 15 international influences on, 16 OTC/nonprescription products, 15, 17–18, 91 promotion definitions and types, 15 sales professionals’ role in, 18 self-regulation of, 16 Africa Algeria, 30–31 biosimilar market growth, 158 Nigeria, 31, 33 North Africa biotechnology products, 126–127 orphan products development, 207 stability testing/climatic zones, 56t6 See also South Africa African/Middle East region biosimilar market growth, 158 biotechnology product regulation, 126–127 regulatory authorities, 30–31, 33 AFTA (ASEAN Free Trade Area), 35, 123 ALCOA (Attributable, Legible, Contemporaneous, Origi- nal and Accurate documents), 11 Andean Community, 124 animal rule (US) models for orphan product development, 204 nonclinical studies, 119–120 ANVISA biological product definition, 156–157 biological product guidelines, 135 generic products in, 80 human blood and plasma products, 196 orphan drug framework, 202, 205
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