Draft Regulation of BPOM on Stability Testing of Health Supplements

Draft Regulation of the Drug and Food Supervisory Agency (Badan Pengawas Obat dan Makanan- “ BPOM ”) on Guidelines for Stability Testing of Health Supplements is still under deliberation. The tests to determine the shelf life of finished product, along with the packaging during the storage period, have been established.

Waliyadin, the Director of Harmonization of Laws and Regulations II of the Ministry of Law, explained the reasons for establishing the regulation.

“This draft is essential for business actors in the health supplements sector and for officers, as a reference for the implementation of stability tests for health supplements” Waliyadin told Hukumonline.

Matters regulated in the body of this draft, include:

1. Guidelines for stability testing which serve as a reference for business actors (in ensuring the quality of health supplements before circulating in Indonesia) and BPOM (evaluation of the implementation of stability tests in the framework of registration);

2. Guidelines for stability testing include test design, evaluation, and statements on the label;

Stability tests must be conducted at a testing facility, specifically an accredited laboratory or an internal industrial laboratory that holds a certificate of good manufacturing practice.