The 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL) are in force. This presentation will go into the unique post-market challenge of change management facing the Foreign Manufacturer when dealing with its MAH counterpart in Japan. In addition, this session will go into the process steps and communications for regulatory (PMDA) notification in case of "significant" changes. Best practices will be explored, particularly with respect to "two-way" communication between the MAH and the manufacturer.

The 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL) are in force. This presentation will go into the unique post-market challenge of change management facing the Foreign Manufacturer when dealing with its MAH counterpart in Japan. In addition, this session will go into the process steps and communications for regulatory (PMDA) notification in case of "significant" changes. Best practices will be explored, particularly with respect to "two-way" communication between the MAH and the manufacturer.