Europe's regulators at the European Medicines Agency are seeking assurances that medicines imported from Japan are not radioactive.
Following the radiation leaks from the Fukushima Daiichi nuclear power plant in east Japan in March, EMA said May 3 that it was to take a precautionary approach to whether medicines manufactured close by the plant were contaminated.
It is asking companies with manufacturing facilities located close to the Fukushima plant to test their medicines for three radionuclides, iodine-131, caesium-134 and caesium-137, before they export them to Europe.
The precautionary approach is often used by European regulators. It is aimed at protecting the public from exposure to risk, when a potential risk has been identified but there is no consensus or scientific certainty of its importance. Under the precautionary approach, the burden of proof that there is not a risk falls on those making an action, in this case the manufacturers.
EMA has reminded manufacturers that market authorization holders are responsible for ensuring the continued quality, safety and efficacy of medicines, in effect warning them and any licensees that it is likely they will be held responsible if imported medicines are later found to be radioactive.
The sanctions that EMA can take against manufacturers could include suspension of marketing or manufacturing of the medicines: the agency told EuroPharma Today that market authorization holders are obliged to demonstrate, at any time and upon request from regulatory authorities, that the risk-benefit balance of their product is favorable.
There have been some words of comfort from the Japanese Ministry of Health, Labor and Welfare, who say that the risk to public and animal health from the radiation leaks, if any, "is very small". And EMA notes that only a small number of medicines are manufactured in facilities close to the Fukushima nuclear plant, and could therefore be potentially affected by radiation.
John Davis (j.davis@elsevier.com)
