Consideration of ethnic differences in approvals for anti-HIV medicines in Japan: Evaluation based on pharmacokinetic studies and post-marketing data.

More than 30 anti-HIV drugs have been approved in Japan using data from dossiers submitted to the United States or European regulatory authorities since 1998. These drugs were approved with the same dosage and administration regimes as in the United States and Europe, using data from pivotal studies that rarely included any Japanese patients, whereas pharmacokinetics (PK) studies in Japanese subjects have been previously required by the Japanese authorities. There have not been any clinically meaningful ethnic differences observed in the PK data from Japanese studies, and no issues with efficacy or safety have been identified as these drugs were marketed. The absence of ethnic differences in PK, efficacy and safety data for over 30 anti-HIV medicines has reached the state of 'the need for bridging data will lessen with experience' in ICH-E5. It may not be necessary to consider biological ethnic differences in the approval of anti-HIV drugs anymore.