In an effort by the Head of National Agency for Drugs and Foods Control (Badan Pengawas Obat dan Makanan– “ BPOM ”) to implement the adequate supervision of industrial pharmaceutical activities, as originally addressed under Regulation of the Minister of Health (“ Minister ”) No. 1799/MENKES/PER/XII/2010 on Industrial Pharmaceuticals, as amended through the issuance of Regulation of the Minister No. 16 of 2013 (“ Regulation 1799/2010 ”), [1] the BPOM has issued Regulation No. 35 of 2019 on the Reporting of Industrial Pharmaceutical Activities (“ Regulation 35/2019 ”).

Reporting Guidelines for Pharmaceutical Manufacturers Updated
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