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

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