Japan’s Foreign Inspections Reveal Communication Chain Gaps

Foreign inspections by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are revealing gaps in the communication chain between marketing authorization holders in Japan, their overseas suppliers and the Japanese caretakers of the supplier’s master files, PMDA’s Liaison Officer with EMA Yoshikazu Hayashi reported at the annual meeting of the Active Pharmaceutical Ingredient Council (APIC) in Barcelona, Spain in late October.

Communication between the parties is emerging as a problem area as Japan’s experience grows in conducting inspections of foreign API manufacturers and other suppliers listed in marketing authorizations and master files.

The communication problems can stem from a lack of knowledge in some of the master file (MF) caretakers, Hayashi cautioned. Due to lack of knowledge, the Japanese caretakers “sometimes fail to provide adequate information to overseas manufacturers holding master files, which makes it difficult for them to take appropriate actions.”

Japan’s 2005 Pharmaceutical Affairs Law (PAL) created a master file system similar to that in the US and Europe, which provides API manufacturers the opportunity to file confidential information directly with PMDA. Previously, the information only flowed through the sponsor.

However, the MF holder must appoint and work through a “caretaker” located in Japan, who serves as the MF registrant and managerial contact throughout the review and marketing stages.

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