Related Experiment Video
Updated: Sep 30, 2026

Pharmacological and Functional Genetic Assays to Manipulate Regeneration of the Planarian Dugesia japonica
Published on: August 31, 2011
Response to Nature's editorial regarding the Japanese legal system for regenerative medicines
Daisaku Sato1, Yuji Arakawa2, Soichiro Isobe2
1Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
Abstract:
Nature's editorial, dated 10 December 2015, made several criticisms of the new Japanese conditional and time-limited marketing authorization system for regenerative medical products. We believe these comments were based on a misunderstanding of the purpose of the regulations, which are patient-oriented, offering patients access to promising regenerative medicines in a timely manner at reasonable expense while also ensuring the efficacy and safety of the medicines. The new regulatory system represents an attempt by Japan to accommodate unmet medical needs, particularly for life-threatening diseases, and is in line with current global regulatory trends to enable early patient access to new therapies.
Related Concept Videos
Bioremediation
Stem Cell Therapy for Tissue Regeneration
Types of Stem Cells used in Stem Cell Therapy
The two main cell types that...
Drug Regulation
Prescription, Nonprescription and Orphan Drugs
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
Drug Control Governance: Regulatory Bodies and Their Impact
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

