The Indonesian FDA, in collaboration with the World Health Organization (WHO), is developing comprehensive guidelines for the regulation of radiopharmaceuticals used in nuclear medicine. Currently, only 11 out of 44 radiopharmaceutical products are approved by the Indonesian FDA, while the rest are supplied through a special access scheme for critical patients. The new guidelines will ensure the safety, quality, and efficacy of radiopharmaceuticals, as well as enhance healthcare standards in the country. Experts from universities, regulatory agencies, and hospitals are actively participating in the drafting process, which includes benchmarking with other regulatory agencies. The guidelines are expected to be released in early 2024.
Mon, 21 Aug 2023 10:52:16 GMT | World Health Organization