title: Recent trends and success factors in reducing the lag time to approval of new drugs in Japan.
abstract: For many years, approvals of new drugs in Japan have lagged behind those in the United States and Europe. As a result of simultaneous global development strategies, more widespread inclusion of Japan in multiregional clinical trials, and significant reforms and investment in Japan's Pharmaceuticals and Medical Devices Agency reviewer capacity and capability, the drug lag appears to be diminishing. This is allowing new medicines to be approved sooner in Japan, improving the efficiency of drug development and benefiting patients.
authors.affiliation: Collegeville, Pennsylvania, USA.
authors.forename: P K
authors.initials: PK
authors.lastname: Honig
mesh_terms: D002986:Clinical Trials as Topic / Q000639:trends*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000639:trends*; D005060:Europe; D006801:Humans; D007564:Japan; D013997:Time Factors; D014481:United States