Guidelines on Good Manufacturing Practices for Drugs Renewed

In a bid to bring the government’s Good Manufacturing Practices for Drugs (Cara Pembuatan Obat yang Baik– “ CPOB ”) into line with recent developments happening within the fields of science and technology, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan– “ BPOM ”) has issued Regulation on Guidelines for Good Manufacturing Practices for Drugs (“ Regulation 34/2018 ”). [1] Previously, matters pertaining to the CPOB guidelines were addressed under Regulation of the Head of the BPOM on the Implementation of Guidelines on Good Manufacturing Practices for Drugs, as amended by Regulation of BPOM (collectively referred to as “ Regulation 03/2012 ”), which has now has been replaced by Regulation 34/2018. [2] Due to the broad scope of the CPOB guidelines, this edition of Indonesian Legal Brief (ILB) will limit its discussion to the following areas: