The European Commission has requested that the European Medicines Agency (EMEA) review the current shortage of radiopharmaceuticals in the European Union (EU) and develop potential solutions to the supply problem.
The directive comes in the wake of several planned and unscheduled shutdowns of nuclear reactors in Europe that produce medical isotopes such as molybdenum-99, the precursor to technetium-99m.
Just last month, the Nuclear Research and Consultancy Group (NRCG) in the Netherlands cautioned that it would be at least November before it could resume production at the High Flux Reactor in Petten.
The EU estimated that the supply of molybdenum and technetium generators currently is approximately 50%. To increase their supply, one option is for companies to make minor changes in their manufacturing processes to allow for other sources of radionuclides. The EMEA is working with member states and marketing organizations to facilitate prompt amendments of national marketing authorizations for alternative production.
In its assessment of the current situation, the Committee for Medicinal Products for Human Use (CHMP) concluded that radionuclide-containing products currently are not affected by the shortage. The panel also found that for those products that are to be radiolabeled before use and adversely affected by the issue of generator supply, alternative treatments or diagnostic procedures are still available.
Related Reading
Dutch reactor opening delayed another month, September 19, 2008
Dutch reactor down two more months, September 8, 2008
AECL: Increased production won't cover demand, August 29, 2008
SNM has 'serious concerns' over isotope situation, August 28, 2008
AECL monitors isotope supply after Dutch shutdown, August 26, 2008
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