Kamis, April 13, 2023

BPOM Preparing Guidelines for Traditional Medicinal Efficacy Claims: Input from the General Public Can Be Submitted until 13 April 2023

The Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan - "BPOM") is currently preparing a Draft Regulation of 2023 on Guidelines for Traditional Medicine Efficacy Claims ("Draft Regulation"). In this regard, inputs on the Draft Regulation may be received by BPOM from the general public until a deadline of 13 April 2023 and can be submitted through the following official link: https://bit.ly/Masukan-KlaimOT2023.
Traditional medicine business actors (i.e. industries, small-scale enterprises, micro-scale enterprises or importers) are required to affix efficacy claims ("Claims") to the packaging of circulated traditional medicines whenever registering traditional drugs.
The said Claims guidelines encompass: 1) Basic principles of Claims; 2) Types of Claims; 3) Evidence of Claims; 4) Supporting documents for Claims; and 5) Examples of Claims. Details of these matters are comprehensively elaborated upon under the Appendix to the Draft Regulation.
Any Claims that were affixed prior to the promulgation of the Draft Regulation must be brought into line with the new Claims guidelines within 24 months of said promulgation.

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The Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan - "BPOM") is currently preparing a Draft Regulation of 2023 on Guidelines for Traditional Medicine Efficacy Claims ("Draft Regulation"). In this regard, inputs on the Draft Regulation may be received by BPOM from the general public until a deadline of 13 April 2023 and can be submitted through the following official link: https://bit.ly/Masukan-KlaimOT2023.
Traditional medicine business actors (i.e. industries, small-scale enterprises, micro-scale enterprises or importers) are required to affix efficacy claims ("Claims") to the packaging of circulated traditional medicines whenever registering traditional drugs.
The said Claims guidelines encompass: 1) Basic principles of Claims; 2) Types of Claims; 3) Evidence of Claims; 4) Supporting documents for Claims; and 5) Examples of Claims. Details of these matters are comprehensively elaborated upon under the Appendix to the Draft Regulation.
Any Claims that were affixed prior to the promulgation of the Draft Regulation must be brought into line with the new Claims guidelines within 24 months of said promulgation.

......