BPOM’s Regulatory Updates Enhance Compliance and Foster Industry Growth
BPOM, through the Directorate of Standardization for Traditional Medicines, Health Supplements, and Cosmetics, conducted a socialization event on BPOM Regulation No. 15 of 2024 regarding health supplement registration and BPOM Regulation No. 16 of 2024 concerning contamination limits in cosmetics. Both regulations emerged following public consultation and harmonization, and various stakeholders attended the socialization event.
The Deputy for Supervision of Traditional Medicines, Health Supplements, and Cosmetics, Mohamad Kashuri, opened the socialization on Thursday (October 24, 2024). This hybrid event gathered all stakeholders in the fields of health supplements and cosmetics, including representatives from associations and industry players, external laboratories, ministries/agencies, academics from universities, professional organizations in health, and consumer organizations in Indonesia. Participants also included representatives from technical implementing units at the central level and Balai Besar/Balai/Loka POM.
Accelerated Evaluation Services to Meet Industry Needs
Mohamad Kashuri announced significant advancements by BPOM in raw material studies, notably the acceleration of evaluation services. BPOM reduced the service level agreement (SLA) from 85 working days to just 10 for qualifying study proposals. This fast-track evaluation meets the needs of industry players, enabling quicker access to study results.
Dian Putri Anggraweni, the Director of Standardization for Traditional Medicines, Health Supplements, and Cosmetics, elaborated on updates in BPOM Regulation No. 15 of 2024, which increased the maximum daily limit of selenium for pregnant and breastfeeding women from 60 mcg/day to 65 mcg/day. Additionally, BPOM Regulation No. 16 of 2024 introduced changes in contamination limits in cosmetics, expanding testing facilities to include internal laboratories with Good Manufacturing Practice (GMP) certification and lowering the limit for 1,4-Dioxane from 25 ppm to 10 ppm. These updates align with the ASEAN standards established during the ACSB meeting in 2019.
Stakeholder Reactions Highlight Importance of Regulatory Updates
During the Q&A session, Dr. Stefani Christanti, a representative from the Directorate of Nutrition and Maternal and Child Health of the Ministry of Health, expressed that the update of these BPOM regulations is highly anticipated. She thanked BPOM for issuing Regulation No. 15 of 2024, which addresses the needs related to micronutrient supplements for pregnant women, specifically multi-micronutrient supplements (MMS).
Similarly, a representative from the Indonesian Health Supplement Entrepreneurs Association (APSKI) conveyed their appreciation to BPOM for these regulations. The introduction of these regulations not only benefits local producers but also supports Indonesia in expediting the export process, particularly for MMS products.
The day’s socialization activities continued with the launch of the Guidelines for the Assessment of Natural Product Medicines, Health Supplements, and Cosmetics. A consultation desk (DEKORASI) was also introduced to enhance assessment services at the Directorate of Standardization for Traditional Medicines, Health Supplements, and Cosmetics.
Sources:
