CMC/GMP Procedures and Interpretations Can Pose Challenges For Foreign Firms in ICH Member Japan

While ICH has had a strong harmonizing influence on Japan’s CMC review process, outside pharmaceutical firms continue to wrestle with understanding and implementing the interpretations and expectations around timeframes, formatting, level of detail and procedural requirements for licensing products in Japan.

The 2004 Pharmaceutical Affairs Law (PAL) established the framework for modifying Japan’s regulatory system to align more closely with those in the US and EU.  Its subsequent evolution and the CMC and GMP challenges remaining for foreign manufacturers supplying to Japan were addressed at a session of the November ISPE annual meeting focused on new and emerging regulations and guidelines in the Asia Pacific region.

The session provided a forum for ISPE’s recently-formed Asia Pacific Focus Group (APFG) to share its knowledge about and experience with CMC/GMP developments across the Pacific rim countries.  Merck Associate Director Pramod Kotwal, a member of the APFG, addressed the Japanese system in particular and the nuances and differences that need to be addressed in interacting with it.

Kotwal covered:  ● the revised PAL ● a pilot allowing certain information to be pre-reviewed prior to submitting the marketing application ● CMC requirements for clinical trials ● the Japanese New Drug Application (JNDA) CTD structure and its unique aspects ● post-approval submissions and bioavailability/bioequivalence (BA/BE) guidelines, and ● GMP compliance and inspections for site accreditation, quality agreements, and batch release.

[Kotwal’s analysis is provided for subscribers here.  Non-subscribers can purchase the full ten-page story for $195 by contacting Karen Bertani (  For subscription information, click here.]