The 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL) are in force. This presentation will explore the Quality Interface Agreement, a necessary document which underscores the high level of "control" to be exhibited by the Japanese Marketing Authorization Holder (MAH) over its foreign manufacturer (FM). The session will go into the key relationship between the foreign manufacturer and the MAH/DMAH, the basis and rationale for an agreement, minimum requirements, recommended points to consider as well as potential pitfalls and best practices.

The 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL) are in force. This presentation will explore the Quality Interface Agreement, a necessary document which underscores the high level of "control" to be exhibited by the Japanese Marketing Authorization Holder (MAH) over its foreign manufacturer (FM). The session will go into the key relationship between the foreign manufacturer and the MAH/DMAH, the basis and rationale for an agreement, minimum requirements, recommended points to consider as well as potential pitfalls and best practices.