Review of Laws, Regulations, and Uses of Off-label Drugs in Indonesia

01 June 2017

Off-label use is defined as the use of a drug outside the scope of its approved label. To address the lack of evidence related to the practice and use of off-label drugs, this report reviewed the laws, regulations and policies related to the off-label use of select medicines in Indonesia, to inform the safety, clinical benefit, value for money, budgetary impact and social and ethical effects.

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Research / discussion papers
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