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Center for Drug Discovery, Drug Discovery and Clinical Research Promotion Unit, Pharmaceutical and Medical Device Regulatory Science Project Lab
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A lab that connects drug delivery technologies with regulatory science.
AboutAbout the lab
Whoever masters regulation masters innovation.
Building on the development and advancement of innovative drug discovery technologies, the field of Regulatory Science for Pharmaceuticals and Medical Devices pursues drug discovery research focused on the molecular basis of biological barriers, as well as regulatory science research.
Its research also covers drug delivery to the brain, noninvasive administration technologies such as transdermal and oral delivery, the development of disease biomarkers, and the creation of new drug candidates.
Through education in regulatory literacy and regulatory communication, the lab aims to train professionals for health and medical innovation who are also well versed in regulatory science.
The lab's mottos are "No regulation, No medical innovation" and "Whoever masters regulation masters innovation."
Key terms
- Biological barrier
- A mechanism that separates the inside and outside of the body or of tissues. Tight junctions, which seal the gaps between epithelial and endothelial cells, form its basis
- DDS
- Drug delivery system. Technology for delivering a drug to where it is needed, in a suitable form
- Regulatory science
- Science used to evaluate the efficacy and safety of pharmaceuticals and medical devices and to inform approval and regulatory decisions
NewsLab news
A doctoral student received the Best Poster Presentation Recognition of the Early Career Award at Eurotox2026
An Assistant Professor received an Outstanding Oral Presenter Award at the 16th Annual Meeting of the Society for Regulatory Science
A student received a Student Excellent Presentation Award at the 145th Annual Meeting of the Pharmaceutical Society of Japan
A student received a Student Excellent Presentation Award at the 144th Annual Meeting of the Pharmaceutical Society of Japan
ResearchResearch themes
The lab develops technologies for delivering drugs to patients and for diagnosing and treating diseases, and pursues this work in connection with regulatory science research. Its areas include biological barriers, central nervous system disorders, gut microbiota-based drug discovery, functional excipients, and digital technologies in medicine.
*Illustrative imageDrug Discovery Focused on Biological Barriers
As biological barriers separating the inside and outside of the body and of tissues, organisms have acquired tight junctions, which seal the gaps between epithelial and endothelial cells. Focusing on their molecular basis, the lab develops DDS technologies and methods for diagnosing and treating diseases.
*Illustrative imageDiagnosis and Drug Delivery for Central Nervous System Disorders
For neurodegenerative and psychiatric disorders, which are increasing with population aging, the lab develops DDS technologies that lead to therapeutics, as well as diagnostic technologies for these diseases.
*Illustrative imageEvaluation Methods for Gut Microbiota-Based Drug Discovery
Gut microbiota-based drug discovery requires analysis of drug-drug interactions in a way that differs from conventional approaches. The lab is developing methods for evaluating efficacy and safety that are specific to this type of drug discovery.
*Illustrative imageDevelopment of Novel Functional Excipients
The lab develops functional excipients such as vaccine adjuvants and absorption enhancers, aiming to develop technologies that allow all pharmaceuticals to be administered in patient-friendly forms.
MembersFaculty
The members of the field of Regulatory Science for Pharmaceuticals and Medical Devices consist of faculty members, doctoral and undergraduate students, secretaries, and laboratory assistants.As of 2026
- ProfessorMasuo Kondoh
- Assistant ProfessorYuki Niwa
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Report an errorAbout the images
The top and research theme images are illustrative and were not taken at the lab. They are cropped from Wikimedia Commons images. Cropped CC BY-SA images are provided under the same CC BY-SA license as the original (version shown on each line).
- Top image: “HK Chai Wan IVE Pharmaceutical Science Laboratory Angelica sinensis Tablets Room 516” Chlaborewan / CC BY-SA 3.0 (cropped)
- Drug Discovery Focused on Biological Barriers: “Honeycomb cells-2” Zhiguo.he / CC BY-SA 4.0 (cropped)
- Diagnosis and Drug Delivery for Central Nervous System Disorders: “MRI brain tumor” Bobjgalindo / CC BY-SA 4.0 (cropped)
- Evaluation Methods for Gut Microbiota-Based Drug Discovery: “Gut-brain-microbiome axis” U3239091 / CC0 (cropped)
- Development of Novel Functional Excipients: “Penthenol nasal spray” Maxim Masiutin / CC0 (cropped)
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