Socialization on Draft BPOM Regulation on the Implementation of Monitoring the Side Effects of Traditional Medicines, Quasi Drugs and Health Supplements.

Published on 15 November 2022

On the 6th of October, EuroCham attended the National Drug and Food Control Agency (BPOM) socialization on the Implementation of Monitoring the Side Effects of Traditional Medicines, Quasi Drugs, and Health Supplements. The socialization was led by Irwan (Director of Supervision of Traditional Medicines and Health Supplements of BPOM) and Drh. Rachmi Setyorini (Director of Standardization of Traditional Medicines, Health Supplements, and Cosmetics).

The first session highlights the lack of regulation in monitoring the side-effects of quasi-drugs stems from the circulation and distribution of quasi-drugs. Therefore, the BPOM ensures that they will provide a strong legal umbrella based on the Regulation No. 4 of 2021 over the side-effects of quasi-drugs. The second session emphasized the constraints for business players in regards to Regulation No. 17 of 2019 regarding the Quality Requirement for Health Supplements.

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