Regulatory Focus™ > News Articles > Japan Looks to Overhaul Compassionate Use Regulations

Japan Looks to Overhaul Compassionate Use Regulations

Posted 14 March 2012 | By Alexander Gaffney, RAC 

The Japanese government is taking steps toward overhauling regulatory provisions that would allow seriously ill patients to access unapproved products under 'compassionate use' provisions, reports Reuters.

"Japan is considering allowing the use of drugs and medical devices that have already been approved in places such as the United States and Europe and which are undergoing clinical trials in Japan," said Toshio Miyata, assistant director at the licensing division of the Pharmaceutical and Food Safety Bureau, to Reuters.

Compassionate use programs typically serve terminal patients who have not responded well to existing treatments and are out of treatment options.

Miyata told Reuters the government hopes to submit legislation to parliament as early as this year, although no timeframe had been set and many details needed to be worked out.

Read more:

Reuters - Japan may open $96 billion drugs market further

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