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Japan: New GLP Updates

In accordance with the new Pharmaceutical Affairs Law (PAL), which went into effect on April 1, 2005, the Ministry of Health, Labor, and Welfare (MHLW) issued an update on Good Laboratory Practice (GLP) in Notification 0331030. This notification clarifies that GLP is... Read More

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Japan’s New GVP Updates

Japan’s new Pharmaceutical Affairs Law (PAL), effective as of April 1, 2005, outlines the new post-marketing safety measures, also known as Good Vigilance Practice (GVP). This regulation clarifies the responsibilities of distributors of medical devices, drugs, quasi-drugs, and cosmetic products. All Marketing... Read More