Since 1 April 2007, all companies marketing originator drugs in Japan must perform post-marketing surveys on new drugs so that efficacy and safety can be reconfirmed by re-examination by the MHLW for a specified period of eight years. Applications for generic drugs cannot be filed until completion of the re-examination and expiration of patents—which last for 20 years in Japan. Brand-name products are protected from generics during this period.

Equivalency of generic drugs—that are supposed to be equivalent to new drugs—are examined by the MHLW through its Pharmaceutical and Medical Devices Agency based on the drug organisation’s research on equivalency to already approved items.

The Japanese government has set a target to raise the share of generic medicines by volume to 30% or more by 2012. The MHLW established the ‘Action Programs for Promoting Safe Use of Generic Medicine’ in October 2007 and efforts have been made in accordance with this programme to gain the trust of patients and medical professionals with regard to generic medicines.

Bioequivalence guidelines
These guidelines are specifically related to bioequivalence studies for generic products:

Guidelines for bioequivalence studies of generic products
December 2006
www.nihs.go.jp/drug/be-guide%28e%29/be2006e.pdf

Guidelines for bioequivalence studies of generic products for topical use
7 July 2003
www.nihs.go.jp/drug/be-guide%28e%29/Topical_BE-E.pdf

Related article

Japanese guidelines for biosimilars

Reference

1. GaBI Online - Generics and Biosimilars Initiative. Japanese guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 June 23]. Available from: www.gabionline.net/Guidelines/Japanese-guidelines-for-biosimilars