From June 10 to 12, the PMDA held the “PMDA-ATC Over-The-Counter (OTC) Drugs Seminar 2025 for NPRA, Malaysia”.
The seminar was held upon the request from National Pharmaceutical Regulatory Agency (NPRA). It was a hybrid format, attending 3 regulators in-person and 37 regulators by online. Through the 3-day seminar, PMDA and MHLW staff members shared regulation of OTC drugs and medical gases, international cooperation in OTC drugs (Self-CARER) and PMDA’s experiences of OTC drug review. NPRA shared their regulations, and both sides actively exchanged views and opinions. In addition to lectures, the 3 participants visited OTC drug manufacturing site and learned manufacturing control and discussed OTC drug development.
The PMDA continues to collaborate with NPRA in capacity building.
See attached program[169 KB]