Abortion Pill: Company Files for Approval in Japan

The medication is recognized as the international gold standard for first trimester medical abortion and is on the World Health Organization (WHO) list of essential drugs for abortion.

A successful submission in Japan would signify the first approved medical abortion drug in Japan and would follow launches in Australia and Canada and most recently in South Korea, where a submission to health authorities will be made later this year. Available in 80 countries, the abortion pill has maintained an outstanding safety record throughout the world.

The drug combination of mifepristone and misoprostol, the first combination pack worldwide, will be known in Japan as MEFEEGO™. The application to the Pharmaceuticals and Medical Devices Agency (PMDA) is based on the results of a Japanese Phase III clinical trial consisting of 120 women aged 18 to 45 years old. If the drug is approved, the 156,430 Japanese women who had surgical abortion procedures in 2019 alone will have another therapeutic option based on their individual need. 

Around 73 million induced abortions take place worldwide each year. Global estimates demonstrate that 45% of all induced abortions are unsafe. According to the WHO, abortion is a simple and safe healthcare intervention that can be effectively managed by a wide range of healthcare professionals using medication or a surgical procedure.

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