Monitoring of medicinal products of Japanese origin

messages in brief | 29/04/2011

The European authorities are working with their European and international regulatory partners to monitor pharmaceuticals manufactured in Japan for the potential risk of radioactive contamination as a result of the leakage of radioactivity from the Fukushima Daiichi nuclear power plant.

Information sharing with the relevant Japanese authorities, the Ministry of Health, Labor and Welfare and the Ministry of Agriculture, Forestry and Fisheries, as well as other global regulatory partners, assures that there is very little, if any, risk to humans and animals.

Drug licensees are responsible for ensuring the ongoing quality, safety and efficacy of medicines. Reference is made to the European Union (EU) measures for food and feed.

Marketing authorization holders of medicinal products manufactured in whole or in part in those Japanese prefectures close to the nuclear power plant (Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Yamagata, Niigata, Nagano, Yamanashi, Saitama, Tokyo and Chiba) are encouraged to test their products for the content of radionucleotides iodine-131, cesium-134 and cesium-137 before export from Japan. According to available information from Japanese companies, these measures are required for only a few pharmaceuticals, as only a small number are manufactured in these prefectures.

The implementation of these tests is planned as an interim measure. A revision of the safety measures based on previous experience and the results obtained is expected.


Further information:

Japan earthquake

European Medicines Agency



Further inquiries:

AGES PharmMed

Communication Management



Further inquiry note