The EMEA has released a public statement on the current shortage of radiopharmaceuticals in the EU.  The main trigger for the current shortage has been the temporary closure of the reactor at Petten (the Netherlands); this is not expected to be operational again until the end of November 2008 at the earliest. Other reactors have also been closed for planned maintenance, limiting the supply of radionuclides in the EU.

The Committee for Medicinal Products for Human Use (CHMP) has analysed the impact of the current supply issue on the seven radiopharmaceuticals that are approved centrally, and concluded the following:

• Those that are radiolabelled in the hospital with a generator prior to their use (Leukoscan, NeoSPECT, and Zevalin) – alternative treatments or diagnostic procedures are available.

• Those that contain a radionuclide (DaTSCAN, Quadramet, Ytracis and Yttriga) – these are not affected by the shortage.

In addition, a large number of radiopharmaceuticals are authorised by national competent authorities. The supply of 99Mo/99mTc generators is at present estimated to be reduced by 50%.  A possible solution would be for companies who make these generators to make minor changes to their manufacturing processes to allow for other sources for the radionuclides, and the EMEA has been working with Member States and marketing authorisation holders to facilitate prompt amendments of the national marketing authorisations for this alternative manufacturing process.

The EMEA is continuing its analysis of the current situation with respect to all radiopharmaceuticals authorised in the EU, and will communicate at a later stage on any further steps taken.