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