- The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan – "BPOM") recently issued Regulation No. 2 of 2023, which has been in force since 10 January 2023. This new regulation has been issued in order to provide a set of guidelines for the evaluation of the safety and/or quality of drugs and drug materials in relation to nitrosamine contamination.
- The new framework states that pharmaceutical industries are required to carry out safety and/or quality evaluations in order to ensure that the nitrosamine contamination threshold complies with the applicable safety and/or quality standard and/or requirements. Said evaluations should be carried out in relation to drugs for which distribution licenses have been applied for and/or drugs for which distribution licenses have already been issued by the Head of BPOM.
- The references provided in the guidelines for the evaluation of drugs address the following aspects: 1) Information regarding nitrosamine contamination and interim daily consumption limits; 2) Development of analysis methods and examples in order to calculate the nitrosamine contamination limit based on maximum daily dosage; and 3) Risk evaluation steps.
- It should also be mentioned that evaluations of drugs must also be carried out in compliance with laws and regulations which address the following matters: 1) Criteria for and the registration of drugs; 2) Good drug manufacturing practices; and/or 3) Withdrawal from circulation and destruction of any drugs that fail to meet the relevant standards and/or requirements relating to safety, benefits, quality and labeling.
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