Approval for the Implementation of Bioequivalence Testing.
UMKU Details
Parameter: All
Authority: Minister/Head of Agency
Requirements and Obligations:
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1. Evidence of Payment of PNBP
Duration: -
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2. Compliance with the Standards and Requirements for the Approval of Bioequivalence Testing
Duration: -
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3. Compliance with the Standards and Requirements for the Approval of Clinical Trials
Duration: -
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4. Good Laboratory Practices (GLP) Standards
Duration: -
Obligations:
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1. Conduct Bioequivalence Testing in accordance with the approved protocol, Bioequivalence Testing Procedures, Good Clinical Practice (GCP) standards, and Good Laboratory Practices (GLP) during the conduct of bioequivalence testing.
Duration: -
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2. Report serious drug adverse effects.
Duration: -
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3. Report changes/amendments to bioequivalence testing documents.
Duration: -
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4. Report the completion of bioequivalence testing.
Duration: -
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5. Report the results of bioequivalence testing for drugs to be submitted for marketing authorization in Indonesia, submitted along with the drug registration documents.
Duration: -
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