While the US and EU follow ICH’s Q12 guidelines for post-marketing drug approval changes, Japan does not. Post-marketing changes in Japan require applications for partial change approval and minor change notifications for low and high-risk changes. In Japan, these take a lot of time and effort to be completed. Currently, there are no simple measures for moderate risk changes or annual reports in Japan.
On October 13, a Japanese government group decided to change current post-drug approval changes for both manufacturing systems and quality assurance on a pilot basis. Going forward, moderate post-approval risk changes will now be included as a subcategory of partial change applications and simpler to do, and low-risk changes will be part of a new annual report program. Generally, Japan’s drug requirements are usually very time-consuming and more demanding than those in the West. Japan’s MHLW wants to increase international harmonization and hence lessen the load on drug companies. In addition to the above changes, the same Japanese government group will look to reduce the burdens of Japanese GMP inspections, remove the complexities of drug description in an approval document, reduce the current detailed manufacturing requirements, etc.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------