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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.

journal_name

J Clin Epidemiol

journal_title

Journal of clinical epidemiology

authors

Darmansjah I,Wardhini S

doi

10.1016/0895-4356(91)90111-l

subject

Has Abstract

pub_date

1991-01-01 00:00:00

pages

39S-43S

eissn

0895-4356

issn

1878-5921

pii

0895-4356(91)90111-L

journal_volume

44 Suppl 2

pub_type

杂志文章

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