Socialization of Policy on Approval for Shipping Radioactive Materials Produced by Domestic Cyclotrons
Kembali 22 September 2025 | Berita BAPETEN | 10 lihatThe Nuclear Energy Regulatory Agency (BAPETEN) held a session to disseminate the policy regarding approval for the shipment of radioactive materials produced by domestic cyclotrons in response to recent dynamics in radiopharmaceutical distribution. The event, held online on Tuesday, September 23, 2025, emphasized the importance of monthly forecasting mechanisms and cross-stakeholder coordination to ensure product availability for patient needs while maintaining regulatory compliance.
The event was opened by Asep Saefulloh Hermawan, BAPETEN’s Director of Licensing of Radiation Facilities and Radioactive Sources. In his opening remarks, he stated, "Radioisotope and radiopharmaceutical production can now be carried out domestically. This represents a step forward for national self-reliance and tangible support for strengthening the national industry. In line with this, BAPETEN has established key regulations governing shipment policies from radioisotope and radiopharmaceutical production facilities."
"BAPETEN has established key regulations governing shipment policies from radioisotope and radiopharmaceutical production facilities. Implementation involves clearly defined provisions, including estimated monthly activity quotas, requirements, and specific conditions for certain facilities. This process flow is expected to ensure that supply and distribution operate safely and efficiently while providing legal certainty," he explained.
The session was attended by 64 participants representing cyclotron-based radiopharmaceutical producers, both those currently in operation and those in the development stage. The activity continued with presentations on the "Policy and Approval Mechanism for Shipping Radioactive Substances from Domestic Cyclotrons" by BAPETEN Radiation Inspector Naufal Alif Syarifuddin and BAPETEN Activity Coordinator for the Health Facility Licensing Function Group, Roy Candra Primarsa.
During the discussion session, participants extensively discussed procedures for the final production stage, including contingency planning, as well as the distribution of radiopharmaceuticals to hospitals. It was also noted that emergency situations often necessitate cross-industry backup mechanisms, which frequently present administrative challenges. However, it is believed that with monthly forecasting and more structured coordination, such situations can be better managed in the future.
Through this outreach initiative, BAPETEN expects to further strengthen collaboration with the industry to ensure the continued availability of radiopharmaceuticals for patients, while prioritizing safety and regulatory compliance above all else. [BHKK/SP/Translator: GP]












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