Dr. Tatsuya Kondo is chief executive of Japan’s regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA). Since taking the role in 2008, Dr. Kondo, a qualified neurosurgeon with wide-ranging experience in R&D activities, has been responsible for all the operations of PMDA, including relief for adverse health effects of drugs, drug and medical device reviews, and post-marketing safety measures. In this interview, Dr. Kondo discusses the importance of trust and transparency in his organization’s operations, Japan’s world-leading speed of drug approvals, and how PMDA positions itself in terms of regenerative medicine.
The most important item, these past five years, has been winning the trust of the public, the industry and academia alike
