Pharmaceutical company perspectives on current safety risk communications in Japan.

ABSTRACT: In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire dev

SUBMITTER: Urushihara H 

PROVIDER: S-EPMC3921345 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature