title: The Indonesian Drug Advisory Committee and the drug approval process.
abstract: 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.
authors.affiliation: Department of Pharmacology, University of Indonesia, Medical Faculty, Jakarta.
authors.forename: I
authors.initials: I
authors.lastname: Darmansjah
authors.forename: S
authors.initials: S
authors.lastname: Wardhini
mesh_terms: 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*
chemical_list: D004304:Dosage Forms; D004338:Drug Combinations; D015507:Drugs, Investigational