The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Fisherman's friend lozenges Drug Master File in Japan (Fisherman's friend lozenges JDMF) empowers Fisherman's friend lozenges API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Fisherman's friend lozenges JDMF during the approval evaluation for pharmaceutical products. At the time of Fisherman's friend lozenges JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Fisherman's friend lozenges suppliers with JDMF on PharmaCompass.