Jumat, September 30, 2022

BPOM Preparing Draft Regulation to Amend Provisions on Health Supplement Quality Requirements

In an effort to adapt to current legal requirements as well as recent scientific and technological developments within the field of health supplements, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) is currently preparing a Draft Regulation on the Amendment to Regulation of the BPOM No. 17 of 2019 on Health Supplement Quality Requirements (“Draft Regulation”).
In addition to addressing the results of studies of manufacturing technologies, dosages and benefits, the Draft Regulation also requires natural ingredients that do not take the form of extracts and that are used in the production of health supplements to meet various safety, benefit and quality criteria.
The various forms that are taken by tablets or caplets may contain dry extracts and/or certain simplicia powders. Meanwhile, the various forms that are taken by capsules may contain: 1) Dry extracts; 2) Liquid materials in the form of oils; and/or 3) Certain simplicia powders.
If the abovementioned capsules contain liquid ingredients in the form of oils, then the production of health supplements may utilize: 1) Soft capsules; or 2) Capsules that are made with special technologies for the production of hard gelatin capsules.
If certain quality requirements for health supplements were not previously regulated under Regulation of the BPOM No. 17 of 2019 on Health Supplement Quality Requirements, then business actors must submit review applications to the Head of the BPOM via the Director of Standardization of Traditional Medicines, Health Supplements and Cosmetics. Said applications should be submitted electronically through the official website for the submission of applications for review by the BPOM.
The BPOM is currently soliciting input concerning this Draft Regulation until a deadline of 3 October 2022. Said inputs may be submitted via the following email address: [email protected] cc: [email protected] by downloading the format available at https://bit.ly/Masukan-MutuSK.

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In an effort to adapt to current legal requirements as well as recent scientific and technological developments within the field of health supplements, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) is currently preparing a Draft Regulation on the Amendment to Regulation of the BPOM No. 17 of 2019 on Health Supplement Quality Requirements (“Draft Regulation”).
In addition to addressing the results of studies of manufacturing technologies, dosages and benefits, the Draft Regulation also requires natural ingredients that do not take the form of extracts and that are used in the production of health supplements to meet various safety, benefit and quality criteria.
The various forms that are taken by tablets or caplets may contain dry extracts and/or certain simplicia powders. Meanwhile, the various forms that are taken by capsules may contain: 1) Dry extracts; 2) Liquid materials in the form of oils; and/or 3) Certain simplicia powders.
If the abovementioned capsules contain liquid ingredients in the form of oils, then the production of health supplements may utilize: 1) Soft capsules; or 2) Capsules that are made with special technologies for the production of hard gelatin capsules.
If certain quality requirements for health supplements were not previously regulated under Regulation of the BPOM No. 17 of 2019 on Health Supplement Quality Requirements, then business actors must submit review applications to the Head of the BPOM via the Director of Standardization of Traditional Medicines, Health Supplements and Cosmetics. Said applications should be submitted electronically through the official website for the submission of applications for review by the BPOM.
The BPOM is currently soliciting input concerning this Draft Regulation until a deadline of 3 October 2022. Said inputs may be submitted via the following email address: [email protected] cc: [email protected] by downloading the format available at https://bit.ly/Masukan-MutuSK.

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