Rabu, April 17, 2024

BPOM Plans to Amend Provisions on Manufacture of Medicines Within Hospitals

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing a Draft Regulation ("Draft Regulation") that will amend Regulation of BPOM No. 12 of 2022 on Guidelines for the Proper Manufacture of Medicines Within Hospitals.
In essence, the Draft Regulation introduces the new term, "Radiopharmaceutical" (radiofarma). This term is defined as chemical compounds that contain radioisotopes and that are capable of meeting various pharmacological requirements for use in diagnostics, therapy and clinical medical research into nuclear medicine.
The Draft Regulation also states that the production of medicines (including radiopharmaceuticals) will be exempted in terms of the synthesis of medicines in accordance with prescriptions or doctors’ instructions.

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The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing a Draft Regulation ("Draft Regulation") that will amend Regulation of BPOM No. 12 of 2022 on Guidelines for the Proper Manufacture of Medicines Within Hospitals.
In essence, the Draft Regulation introduces the new term, "Radiopharmaceutical" (radiofarma). This term is defined as chemical compounds that contain radioisotopes and that are capable of meeting various pharmacological requirements for use in diagnostics, therapy and clinical medical research into nuclear medicine.
The Draft Regulation also states that the production of medicines (including radiopharmaceuticals) will be exempted in terms of the synthesis of medicines in accordance with prescriptions or doctors’ instructions.

......