※Health Labour Sciences Research Grant：https://mhlw-grants.niph.go.jp/ ※Japan Agency for Medical Research and Development (AMED)：https://www.amed.go.jp/seika/ 13 Table 3 Contribution to Public Research Groups PMDA also contributes to public medical research. PMDA staffs contribute to the promotion of research as an expert of RS in the public research group, and work together with external researchers toward problem-solving In FY 2023, PMDA staffs were involved as co-investigators in a total of 13 public research groups. More information of the research projects are shown in Table 3 below. For study details, such as study results reports, see the applicable page below. Health, Labourand Welfare Sciences Research Grants. Title A study on quality control and standardization of medical information databases in consideration of international harmonization for appropriate drug safety evaluation Research on optimization and development of guidelines for proper use of medical devices Research for application and operation of the Act on the Safety of Regenerative Medicine, etc. for transplantation of genetically-modified heterologous organs and securing of public health safety Research contributing to revision of analytical guidelines for cost-effectiveness evaluation of drugs / medical devices Research on environmental improvement toward the promotion of global clinical trials in Asian region Regulatory science research on lifecycle management of the pharmaceuticals manufactured, controlled and evaluated by advanced approaches. Research on development of internationally-competitive, next-generation antibody drug manufacturing technology / technical research on physical properties, quality evaluation, and management methods toward practical application of next-generation antibody drugs / technical research on quality evaluation and management methods toward practical application of next-generation antibody drugs Research contributing to development of domestic infrastructure for evaluation methods, etc. to ensure the quality and safety of drugs and promotion of international harmonization Research on standardization of non-clinical toxicity terms and establishment of database that contribute to acceleration/increased accuracy of drug safety evaluation Research on development of assessment criteria for effects of psychotropics on driving performance Research on establishment of non-clinical evaluations as an alternative to clinical evaluations related to loading requirements for dental implants. Research on application of medical device malfunction glossary to signal detection and development of supporting tools Research on development of quality, efficacy, and safety evaluation systems for AAV vector-derived gene therapy products using patient samples in in vivo gene therapy Title Research field Pharmaceutical field Medical device field Regenerative medicine and gene therapy field Multiple fields (Pharmaceutical / medical device field) Multiple fields (Pharmaceutical field/regenerative medicine / gene therapy field) Research field Pharmaceutical field Medical device field Regenerative medicine and gene therapy field Contribution to Public Research Groups
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