title: [Compassionate use mechanisms in Europe].
abstract: To be able to use unlicensed medicines for treatment of special patients, there are "Compassionate Use Mechanisms" n Europe. The general principles are defined under EC regulations,but the actual national systems differ per country. They are categorized two types, one is "Nominative" and the other is "Cohort". Nominative systems allow accessing unlicensed medicines on a patient by patient basis, which are called in various ways such as named patient supply, individual patient supply, nominative importations, etc. All of 25 EU countries have this system in some way. Cohort systems are for multiple patients in dedicated hospitals. 10 EU countries have this system. Therefore, these countries have both of nominative and cohort systems. Compassionate Use is a streamlined system for access for patients with serious, life threatening or disabling disease with no licensed alternative in the opinion of the treating physician, and it should be done under the medical responsibility of the treating physician. The company is responsible for providing fair, accurate and balance information to the physician for decision making and also for the quality of the medicinal product. The current Japanese "Private Import System" has caused some problems. I think that we need an appropriate "Compassionate Use system" in Japan.
authors.affiliation: Regulatory Affairs Department, Nihon Schering K.K.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Sugimura
mesh_terms: D015331:Cohort Studies; D003431:Cross-Cultural Comparison; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004346:Drug Information Services; D005060:Europe; D019983:Guideline Adherence; D006801:Humans; D007564:Japan; D007880:Legislation, Drug; D010344:Patient Advocacy; D011786:Quality Control