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Japan Drug Regulatory Updates

Japan has had a flurry of new drug regulations to ease their drug lag problem and make their country more conducive to innovative drugs. As mentioned last month, Japan’s PMDA is now allowing the submission of some innovative drug applications in English and will respond... Read More

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Quick Asian Regulatory Updates

On July 18, the Japanese Ministry of Health, Labor and Welfare (MHLW)  introduced new criteria for excluding certain drugs from mandatory post-marketing surveillance (PMS), traditionally required for newly approved medicines. This initiative aims to mitigate delays and reduce losses in drug availability. The MHLW informed... Read More

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Quick Asian Regulatory Updates 2

Vietnam’s Ministry of Health presented significant amendments to the pharmaceutical law to the National Assembly in June 2024. The 2016 Pharmaceutical Law, which succeeded the 2005 law, initially provided a transparent legal foundation for the pharmaceutical industry and aligned with global standards.... Read More