A long-awaited report from a study group set up under Japan's CentralPharmaceutical Affairs Council has confirmed the safety and efficacy of low-dose hormonal oral contraceptives, according to Ministry of Health and Welfare sources. Naoto Kan, the former Minister of Health and Welfare, announced last July that the CPAC was studying whether or not to allow open sales of birth control pills in Japan in 1997 (Marketletter July 15, 1996).
The OC pill has long been officially banned in Japan because of questions of safety and efficacy, due to fears that it would lower morals and, in more recent years, because of worries that it would lead to an increase in AIDS. Industry sources have estimated that only some 200,000 Japanese women are on the pill, ostensibly for "menstrual disorders."
Official Approval Soon? The new report is expected to lead to Ministry approval of OCs in the very near future, following consultations with the Council on Public Health and official approval by the CPAC towards the end of this month.
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