BPOM Drafts Regulations on Preclinical Testing of Natural Medicines and Health Supplements

The Indonesian Food and Drug Authority (“BPOM”) is currently drafting a BPOM Regulation on Procedures for Obtaining Approval to Conduct Preclinical Testing of Natural Medicines, Quasi-Drugs, Health Supplements, and Cosmetics. Several provisions are addressed in the draft regulation, including the mandatory nature of preclinical testing.

Under the proposed regulation, preclinical testing will be mandatory for natural medicines, quasi-drugs, and health supplements. Such testing must be conducted within the territory of Indonesia for the purpose of product registration with BPOM. The testing covers in vitro toxicity testing and pharmacodynamic testing.

“The obligation to conduct preclinical testing applies to natural medicines, quasi-drugs, and certain health supplements, where the testing is carried out within the territory of Indonesia,” said Dian Putri Anggraweni, Director of Standardization of Traditional Medicines, Health Supplements, and Cosmetics at BPOM.

Meanwhile, preclinical testing for cosmetic products will be voluntary and conducted at the discretion of business actors, particularly where necessary to support the addition or substantiation of product claims. Testing of cosmetic products may employ alternative non-clinical methods that do not involve the use of test animals.