2019 Volume 64 Issue 1 Pages 17-22
The three key services of the Pharmaceuticals and Medical Devices Agency (PMDA) are : 1. relief services for adverse health effects, 2. review and 3. post-marketing safety measures. During the new drug review process, PMDA reviews the quality, efficacy and safety of new drugs for marketing approval using the common technical document (CTD). Thus, the integrity of the CTD data presented by the applicants is very important. Based on the evaluation, some drugs are not approved because they are ineffective or harmful. The PMDA is actively improving the public health and safety in Japan.
