On December 11, 2024, Indonesia released the draft amended Guidelines for Follow-up on Supervision Results of Traditional Medicines, Quasi Drugs, Health Supplements, and Cosmetics for public consultation. This Guidelines primarily outlines BPOM's supervision requirements for cosmetics, natural drugs, quasi drugs, and health supplements in circulation, including:
Supervision items
Supervision results
Supervision methods
Corresponding measures
The draft also includes five annexes clarifying follow-up supervision related to import, manufacturing, distribution, safety, efficacy, quality, labeling compliance, promotion, advertising, clinical trials, and pharmacovigilance for these product categories:
Appendix I: Guidelines for Follow-Up Supervision of Import, Manufacture, and Distribution
Appendix II: Guidelines for Follow-Up Supervision of Safety, Efficacy, Quality, and Labeling Compliance
Appendix III: Guidelines for Follow-Up Supervision of Promotion and Advertising
Appendix IV: Guidelines for Follow-Up Supervision of Clinical Trials
Appendix V: Guidelines for Follow-Up Supervision of Pharmacovigilance


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