EMEA addresses radioisotope shortage; appeals to private industry
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| Government-run isotope labs are becoming sparse with all the shutdowns. Image Source: Institute for Energy Technology |
The agency said that the main trigger for the current shortage has been the temporary closure of the reactor at Petten, the Netherlands—one of the key European production sites of radionuclides. Other reactors have also been closed for planned maintenance, limiting the supply of radionuclides in the EU.
According to the agency, the Committee for Medicinal Products for Human Use has analyzed the impact of the current supply issue on these products. The committee concluded that the radionuclide-containing products are not affected by the shortage. The committee also concluded that, for those products that are to be radiolabelled before use, and therefore could be indirectly affected by the issue of generator supply, alternative treatments or diagnostic procedures are available.
In addition, the EMEA said that a large number of radiopharmaceuticals, including all 99Mo/99mTc generators available in the EU, are authorized by national competent authorities.
The supply of 99Mo/99mTc generators is at present estimated to be reduced by 50 percent, according to the agency. To increase the supply, a possible solution would be for companies who make generators to make minor changes to their manufacturing processes to allow for other sources for the radionuclides.
The EMEA said it has been working with member states and marketing authorization holders to facilitate prompt amendments of the national marketing authorizations for the alternative manufacturing process of the active substance. An ad-hoc procedure using the work-sharing concept for the scientific assessment has been put in place and completed by the CMD, the co-ordination group for mutual recognition and decentralized procedures for human products. Member states will now have to introduce the necessary amendments to the national authorizations.