The Indonesian Drug Advisory Committee and the drug approval process.
The Indonesian Food and Drug Agency began to evaluate drug applications in the early 1970s through an Advisory Committee. This was in response to the perestroika-like policy applied to our drug industry; nowadays there are more than 300 drug companies formulating some 13,5600 drug products. During 1977-1988, 603 drugs were evaluated by the Advisory Committee; 66% were single drugs and 34% were fixed dose combinations. Nine-hundred and twenty-five sessions were needed to arrive at decisions. Most of the applications (88.5%) were reviewed in one or two sessions but 8 drugs took 6-12 sessions. The time needed for assessment may vary from 1 to 3 months (61%), but some have needed almost a year and a half. There were 60% acceptances for single drugs and 35% for fixed combinations.
Darmansjah
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Department of Pharmacology, University of Indonesia, Medical Faculty, Jakarta.
Wardhini
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S
D003906:Developing Countries; D004304:Dosage Forms; D004338:Drug Combinations; D004341:Drug Evaluation / Q000379:methods*; D004345:Drug Industry; D015507:Drugs, Investigational; D006801:Humans; D007214:Indonesia; D010606:Pharmacy and Therapeutics Committee / Q000458:organization & administration*
D004304:Dosage Forms; D004338:Drug Combinations; D015507:Drugs, Investigational