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156:
161:
166:
74:
41:
124:
171:
112:
107:
International
Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
118:
69:
The two main subcommittees of ADEC which were responsible for specific aspects of drug regulation in
Australia:
51:
ADEC provided advice to the
Minister for Health and Ageing and the Secretary of the Department of Health on:
29:
96:, etc.) of drugs proposed for registration (replaced by the pharmaceutical subcommittee of the ACPM).
151:
63:
77:(ADRAC) (replaced in 2010 by the separate Advisory Committee on the Safety of Medicines, ACSOM);
55:
quality, risk-benefit, effectiveness and accessibility of drugs referred to ADEC for evaluation
93:
89:
81:
145:
36:. The committee was originally formed in 1963 and more recently authorised under the
80:
the
Pharmaceutical Subcommittee – which made recommendations to ADEC on the
136:
58:
medical and scientific evaluations of applications for registration of new drugs
33:
85:
62:
An important role of ADEC was the classification of drugs in
Australia into
25:
45:
157:
162:
Medical and health organisations based in
Australia
46:
Advisory
Committee on Prescription Medicines (ACPM)
28:that provided independent scientific advice to the
8:
75:Adverse Drug Reactions Advisory Committee
44:(TGA). In 2010, ADEC was replaced by the
167:National agencies for drug regulation
7:
18:Australian Drug Evaluation Committee
14:
42:Therapeutic Goods Administration
38:Therapeutic Goods Act 1989 (Cth)
125:Health Products and Food Branch
1:
113:Food and Drug Administration
188:
119:European Medicines Agency
32:regarding therapeutic
172:Pharmacy in Australia
30:Australian Government
64:pregnancy categories
179:
94:pharmacokinetics
187:
186:
182:
181:
180:
178:
177:
176:
142:
141:
133:
103:
90:quality control
40:as part of the
12:
11:
5:
185:
183:
175:
174:
169:
164:
159:
154:
144:
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131:External links
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122:
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110:
102:
99:
98:
97:
82:pharmaceutical
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60:
59:
56:
13:
10:
9:
6:
4:
3:
2:
184:
173:
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27:
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137:ADEC website
68:
61:
50:
37:
21:
17:
15:
152:Evaluation
146:Categories
121:(EMEA, EU)
115:(FDA, US)
86:chemistry
84:aspects (
26:committee
101:See also
24:) was a
109:(ICH)
34:drugs
73:the
22:ADEC
16:The
148::
92:,
88:,
66:.
48:.
20:(
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