With the ultimate aim of protecting the public from poor quality imported drugs, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan– “ BPOM ”) has issued Regulation No. 7 of 2019 on Assessments of Fulfillment of Good Drug Manufacturing Practice by Imported Drug Manufacturing Facilities (“ Regulation 7/2019 ”). [1] In general, Regulation 7/2019 addresses the following areas:
Assessments of Fulfillment of Good Drug Manufacturing Practice Requirements by Imported Drug Manufacturing Facilities
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