Natural Medicine Industries Take Note: Eight Types of Risk-Management Program Data Soon to Be Required for Compliance Requirements

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) is currently completing work on a Draft Decree (“Draft Decree”) of the Head of the BPOM on Technical Guidelines for the Application of the Risk-Management Program (Program Manajemen Resiko – “PMR”) at Natural Medicine Industrial Facilities (“Facilities”).[1] If the Draft Decree ultimately comes into force, then this new framework will subsequently serve as a reference for use by natural medicine industries (“Industries”) during the application of the mandatory PMR at their respective Facilities. As a result, the PMR is set to become an integral part of the self-assessment process and should ensure that any natural medicine products that are distributed on a nationwide basis meet applicable safety, efficacy and/or quality requirements.[2]