BPOM Drafts New Regulation on the Procedures for Quasi-Drug Registration

The Drug and Food Supervisory Agency (“ BPOM ”) is formulating a Draft Regulation of BPOM on the Criteria and Procedures for the Registration of Quasi-Drugs (“ RPerBPOM ”). This regulation requires pharmaceutical industries to take into account additional provisions on the importation of finished products, the verification of electronic documents, and the transparency of registration process.

“We ensure that the regulation to be issued will be implementable and capable of supporting a healthy business climate,” said Erni Rachmawati, Head of the Formulation Team for Health Supplements and Quasi-Drug Standards.

This RPerBPOM will replace BPOM Regulation No. 7 of 2023 on Criteria and Procedures for the Registration of Quasi Drugs (“ PerBPOM 7/2023 ”). The regulation introduces a number of new provisions, one of which is that importer recommendations must be obtained by submitting an application to the Head of BPOM and will remain valid for three years from the date of issuance.