Report of the PMDA-ATC CMC Review Webinar 2023 for the Indonesian FDA, Indonesia

The PMDA held the Chemistry, Manufacturing, and Control (CMC) review webinar for the Indonesian Food and Drug Authority (FDA) on March 9, 2023. This webinar was part of the bilateral cooperation based on the Memorandum of Cooperation (MoC) between the Indonesian FDA and the Ministry of Health, Labour, and Welfare (MHLW), signed in August 2021. A PMDA staff member from the Office of New Drug V gave a lecture on CMC review, with 122 Indonesian FDA regulators attending online. Additionally, a Q&A session was held to enhance understanding of the topic.

The PMDA continuously makes efforts to strengthen collaboration with the Indonesian FDA through training
offered by the Asian Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC).

See attached program