National Coordination Meeting (Rakornas) for Nuclear Medicine and Radioisotope and Radiopharmaceutical ProductionKembali 24 November 2023 | Berita BAPETEN
Directorate of Licensing for Radiation Facilities and Radioactive BAPETEN Substances held a National Coordination Meeting in the context of coordination and guidance with stakeholders related to Nuclear Energy Supervision, especially Nuclear Medicine Licensing and Production of Radioisotopes and Radiopharmaceuticals, in Jakarta, on November 17 2023.
The event began with a report from the Chairman of the National Coordination Meeting, the Director of Licensing for Radiation Facilities and Radioactive Substances, BAPETEN, Ishak, reporting that the National Coordination Meeting was attended by the Ministry of Health, BPOM, BRIN, the Indonesian Association of Nuclear Medicine and Molecular Theranostics (PKN-TMI), permit holder agencies, prospective Nuclear Medicine permit holders , Production of Radioisotopes and Radiopharmaceuticals.
The National Coordination Meeting was opened by BAPETEN's Deputy for Licensing and Inspection, Zainal Arifin, in his opening remarks saying "The development of Nuclear Medicine and the Production of Radioisotopes and Radiopharmaceuticals is quite rapid throughout Indonesia. Radioisotope and Radiopharmaceutical Production Permits today are not as easy as in the past. Currently, Radioisotope and Radiopharmaceutical Production Facilities must be built in industrial areas in accordance with BKPM regulations. BAPETEN supports the development of Radiotherapy and Nuclear Medicine as the Ministry of Health's national plan to be built throughout Indonesia."
The speech was continued by Plt. Head of BPOM Lucia Rizka Andalucia, who said "Cancer is one of the priorities with the highest incidence rate in Indonesia, so appropriate detection tools are needed, currently in Indonesia there are only 4 cyclotron machines. Based on lessons learned from India, namely registration is carried out by industries for the first time producing radiopharmaceuticals by the Food and Drug Administration, distribution is carried out under the supervision of the Atomic Energy Regulatory Board through transportation permits and every radioisotope and radiopharmaceutical production industry must have a GMP/CPOB certificate.
"There is a need for benchmarking of regulations from various countries, so there is a need for coordination across ministries/institutions regarding updating the mapping of the latest plans for cyclotron development including safety of distribution of radiopharmaceuticals, product distribution permit regulations, operational regulations for cyclotron facilities, meeting human resource needs and affordability of radiopharmaceutical prices." Strictly speaking.
The event continued with a presentation on "Health Transformation through the Development of Nuclear Medicine Services in Indonesia" by the Director of Service Facilities at the Ministry of Health, Aswan Usman. Meanwhile, the afternoon session continued with a presentation on “BAPETEN Regulation No. 3 of 2021, concerning Radioiostop & Radiopharmaceutical Production Licensing and BAPETEN Regulation No. 6 of 2020, concerning Radiation Safety Requirements in the Production of Radioiostop and Radiopharmaceuticals" by Plh. Director of Supervision of Radiation Facilities and Radioactive Substances - BAPETEN Sugeng Rahadhy, presentation on "CPOB Mechanisms related to Radioisotope & Radiopharmaceutical Production Activities in Indonesia" by Acting Director of Supervision of Production of Drugs, Narcotics, Psychotropics and Precursors BPOM Mudi Yunita, and presentation on "Applying for Marketing Permits Radiopharmaca” by the Director of Drug Registration-BPOM Ria Christine Siagian. This was followed by a panel discussion of all participants regarding the distribution of human resources and calibration of the output of Radiation Measuring Instruments in radiotherapy services.
In the final session, a presentation was delivered on "The Urgency of the Need for Radiopharmaceuticals and Radioisotopes for Nuclear Medicine Services in Indonesia" by the Chairman of the Indonesian Association of Nuclear Medicine and Molecular Theranostics Eko Purnomo and a presentation on "Type A Radioactive Package Testing Mechanism" by the Director of BRIN Nuclear Energy Facilities Management Muhammad Subekti. As well as a panel discussion for all participants regarding packaging testing and certification, special standards for radioactive transportation equipment and other options for radioactive transportation, mechanisms for licensing radioisotopes and distribution permits for radioisotope products as medicines.
The National Coordination Meeting was closed by BAPETEN's Director of Licensing for Radiation Facilities and Radioactive Substances, Ishak, in his closing remarks, saying "in the meeting there are still problems that must be resolved on the agenda of the next meeting, and input regarding licensing that can be received, will be discussed in order to make improvements to every aspect of supervision. [DFPFRZR/Dwiangesti/BHKK/SP/RP]