Report of the PMDA-ATC First-in-Human Training for NPRA

From September 26 to 30, Dr. Zaril Harza Zakaria (Head, Investigational Product Evaluation and Safety Section) and Ms. Tang Sia Chin (Principal Assistant Director, Evaluation & Safety of Investigational New Product Section) from the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia, visited the PMDA and participated in the training programme regarding the conduct of First-in-Human clinical trials. Members from the relevant PMDA offices (Office of International Programs, Office of New Drug, and Office of Cellular and Tissuebased Products) participated in this training, shared their experiences, and discussed various topics with the participants. The Japan Pharmaceutical Manufacturers Association also cooperated in conducting this training, gave lectures, and arranged an on-site tour to the Ukima Plant of Chugai Pharma Manufacturing Co., Ltd.
The PMDA continues to provide training opportunities and contributes to the capacity building of the NPRA.