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
For further information, please contact:
Wongrat Ratanaprayul, Tilleke & Gibbins
wongrat.r@tilleke.com
