Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum

Industry associations have been meeting with Japanese regulators to highlight the problems they are experiencing in Japan’s process for regulating post-approval manufacturing changes, including a lack of flexibility around biopharmaceutial manufacturing changes that results in most requiring prior approval as well as meetings with the agency to resolve unclear expectations.

The Japan Pharmaceutical Manufacturers Association (JPMA) met with Japan’s Pharmaceutical and Medical Device Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW) in the latter part of 2012 to highlight concerns its membership had raised regarding post-approval changes.  Of primary concern were the requirements for reconfirming shelf life and the disparity between Japan’s requirements and those in the U.S. and EU.

A 2013 meeting also brought in the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to provide perspectives from outside of Japan.

The post-approval change regulatory process in Japan and how it compares to approaches in the rest of the world was a key focal point of a CASSS biotech “CMC Strategy Forum Japan,” held in December in Tokyo, at which Japanese industry and regulators were well-represented. Also in attendance were regulators and industry representatives from Asia as well as from Europe and the U.S.

The first of CASSS’ Japan CMC Strategy Forums was held in Tokyo in December, 2012 (IPQ, January 16, 2013). A third in the series will be held in December of 2014, also in Tokyo.

CASSS also hosts a strategy forum in Europe in the spring supported by European regulators, along with the strategy forums it holds in the U.S. in January and July.  The Europe forum this spring will take place May 5-7 in Sorrento, Italy.

Changes are a Japanese and Global Problem

The session on biopharmaceutical post-approval changes at the 2013 Japan meeting included: ● a detailed look by PMDA’s Futaba Honda at Japan’s regulations regarding submissions and changes ● JPMA’s perspectives on the current post-approval change requirements, presented by Takeda’s Takao Kojima ● the difficulties and challenges faced by industry when making post-approval changes in multiple markets by Amgen’s Toshiko Mori-Bajwa, and ● Genentech’s Lynne Krummen on managing post-approval changes using risk-based  comparability concepts.

[Editor’s Note: Honda’s, Kojima’s and Mori-Bajwa’s complete remarks are included below].

[CLICK HERE for the complete story.with more on the post-approval change discussions as well as a review of the discussions on the other four topic areas at the Japan forum.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (  For subscription/license information, click here.]