Ayaka Okamoto PMDA Regenerative Medicine Products Review Division

Since joining the Pharmaceuticals and Medical Devices Agency (PMDA) in April 2018, I have been engaged in both consultation and review of regenerative medical products (cellular and tissue-based products and gene therapy products) in the Office of Cellular and Tissue-based Products. After taking three parental leaves between 2020 and 2023, I returned to the same office in November 2023. Currently, I am involved in review and consultation related to regenerative medical products, as well as consultations related to the Cartagena Act and pre-submission assessments. In the review and consultation of regenerative medical products, I mainly focus on quality and pharmacology aspects, while also collaborating with specialists in non-clinical safety and clinical evaluation.