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March 24, 2023

Practical Law: Life Sciences Regulation in Indonesia 2023

Attorneys in Tilleke & Gibbins’ Jakarta office have contributed a new “Life Sciences Regulation in Indonesia” chapter to Practical Law’s updated Life Sciences Global Guide. The chapter covers a range of regulatory issues related to the development, manufacturing, and selling of pharmaceutical products and medical devices, including the following topics:

  • Pharmaceuticals: Laws and regulatory authorities
  • Clinical trials: Legal, regulatory, and procedural requirements
  • Manufacturing and distribution
  • Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations
  • Data privacy
  • Packaging, labeling, and tracking
  • Biological medicines
  • Medical devices: Legislation and regulatory authorities, definition and classification
  • Healthcare IT
  • Combination products and borderlines
  • Natural health products
  • Developments, reforms, and proposals

Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas.

The full “Life Sciences Regulation in Indonesia” chapter can be accessed on the Practical Law website

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