This message was posted by a user wishing to remain anonymous
My company purchases API manufactured in the EU specifically for our use and we also sell this API to various global partners. Our Japanese partner (who purchased the API through us) wants to deal with API manufacturer directly. They cite PMDA regulations which they say require the Japanese Sponsor company to only setup a QTA agreement with the API manufacturer. We have offered a 3-way QTA, but there are resistant (claiming the above regulations). Do the PMDA regulations not allow for a 3-way QTA? And do the PMDA regulations clearly state that the Japanese Sponsor is required to conduct an independent audit of its "API Manufacturer" or "API Supplier"? Since they purchase the API through my company, aren't we considered the supplier?