Selasa, September 24, 2024

Radiopharmaceuticals Regulated in New Guidelines on Good Manufacturing Practices for Drugs

The Head of the Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan-"BPOM") has amended Regulation of BPOM No. 12 of 2022 on Guidelines for Good Manufacturing Practices for Drugs (collectively referred to as "Guidelines"), through the issuance of Regulation of BPOM No. 17 of 2024 ("Amendment"), which has been in force since 18 September 2024.
In essence, the Amendment redefines the scope of the Guidelines, specifically as they address the following matters: 1) Radiopharmaceuticals as chemical compounds; 2) Radiopharmaceutical preparations in hospitals; and 3) Hospitals.
The Guidelines also state that activities related to the compounding and dispensing of drugs should be carried out in line with official Regulations of the Minister of Health.
The Amendment also affirms that administrative sanctions will be imposed in line with Regulation of BPOM No. 9 of 2024 on Guidelines for Follow-up Measures to the Results of the Supervision of Drugs, Medicinal Substances, Narcotics, Psychotropics, Precursors and Addictive Substances.

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The Head of the Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan-"BPOM") has amended Regulation of BPOM No. 12 of 2022 on Guidelines for Good Manufacturing Practices for Drugs (collectively referred to as "Guidelines"), through the issuance of Regulation of BPOM No. 17 of 2024 ("Amendment"), which has been in force since 18 September 2024.
In essence, the Amendment redefines the scope of the Guidelines, specifically as they address the following matters: 1) Radiopharmaceuticals as chemical compounds; 2) Radiopharmaceutical preparations in hospitals; and 3) Hospitals.
The Guidelines also state that activities related to the compounding and dispensing of drugs should be carried out in line with official Regulations of the Minister of Health.
The Amendment also affirms that administrative sanctions will be imposed in line with Regulation of BPOM No. 9 of 2024 on Guidelines for Follow-up Measures to the Results of the Supervision of Drugs, Medicinal Substances, Narcotics, Psychotropics, Precursors and Addictive Substances.

......