BAPETEN Audience with BPOM
Kembali 14 Maret 2024 | Berita BAPETEN

The Nuclear Energy Regulatory Agency (BAPETEN) held an audience with the Indonesian Food and Drug Authority (BPOM) to coordinate and discuss radiopharmaceutical issues and their supervision on Thursday, March 14, 2024. In this meeting, BAPETEN brought a team from the Directorate of Regulation of Radiation Facilities and Radioactive Materials (DP2FRZR) and the Directorate of Licensing of Radiation Facilities and Radioactive Materials (DPFRZR). The objective of this initiative was to address the issues of the requirement for radiopharmaceutical in Indonesian nuclear medicine facilities especially for hospitals. As is well known, radiopharmaceuticals are pharmaceutical chemicals and radioisotopes combined in chemical compounds for application in biomedical research, therapy, and diagnosis. Hospital patients truly require radiopharmaceuticals; thus, the supply must be kept up-to-date and compliant with medication and radiation safety regulations. Because of this, the activity held at the Office of the Food and Drug Monitoring Agency (BPOM), located on the eighth level of the Red and White Building, addressed potential future actions that the two regulatory organizations might take.


Director of BPOM Drugs, Narcotics, Psychotropics, and Precursors (ONPP) Production Supervision, Bayu Wibisono, welcomed BAPETEN. He expressed his strong support for this coordination effort, saying it will enable BPOM to keep learning more about radiopharmaceuticals and to take the necessary monitoring actions. The session started with an explanation from Mukhlisin, the Director of DP2FRZR, about how BAPETEN's previous monitoring has mostly concentrated on safeguarding against the radiation risks associated with radiopharmaceuticals. Currently, licensing is done through the issue of shipping permissions, transfer permits—which are permits to distribute radiopharmaceuticals—and facility permits, which start with construction permits before operation permits. Along with the challenges, the presentation included the most recent licensing status as reported by a number of hospital and pharmaceutical sector participants. Hospitals are becoming increasingly dependent on radiopharmaceuticals; hence, the Ministry of Health is building facilities to produce these drugs. In order to meet the nuclear medicine facilities in the province or city with radiopharmaceuticals, the Ministry of Health has planned to open a number of hospitals and companies. The issue of small-scale distribution from hospitals to other hospitals—distribution that does not violate existing regulations—then becomes the main topic of discussion. It is intended that this meeting will serve as a springboard for more focused in coordinating on a number of issues.


Representatives from the Deputy for Control of Drugs, Narcotics, Psychotropics, Precursors, and Addictive Substances were also present at this meeting. Following BAPETEN's presentation, BPOM provided a brief overview of the monitoring procedure and the actions the BPOM has taken to address this issue. Policies are in place to allow some hospitals to fulfill their contractual obligations to supply other hospitals while maintaining drug quality standards.


Following this meeting, a number of agreements were made that call for further coordination to discuss specifics like how to exchange data and information about the distribution and licensing of radioisotope and radiopharmaceutical facilities processed at BAPETEN, how to integrate the licensing and supervision processes, and how to design legal instruments so that they work in concert with one another. In addition, BPOM will create a dedicated task force to oversee this radiopharmaceutical. (DP2FRZR/Vatimmah/BHKK/CD/GP)

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