Japan’s National Diet Congress will soon start discussions on the approval of the revised Act On Securing The Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (known as the PMD Act), which includes provisions set to tighten rules for conditional approvals, drive R&D for pediatric indications and governing the use of real-world data (RWD) in post-marketing research.
Japan Set To Approve Broad Revisions To PMD Act
Venture Funding Plans Also Clarified
Multiple, wide-ranging revisions to Japan's PMD Act, including provisions on pediatric R&D, use of real-world data and cell therapies, look set to receive formal political approval within the next few months. There is also more clarity on a controversial scheme to support venture companies.
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