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Managed Access Program (MAP) is an umbrella term used when defining an ethical solutions-based approach to provision of unapproved medicines for patients with unmet medical needs, typical of the following scenarios when drugs: : * Are still in clinical development and have yet to be approved : * May never be approved , but still have medicinal value for a very small population : * Are approved in one country, but not in another : * Have been discontinued in a particular market : * Are an alternative to a drug discontinued globally : * Are approved but not yet commercialized : * Are used off-label in some countries A variety of terms are used to describe these programs including: : * Expanded Access : * Early Access : * Compassionate Use : * Named Patient : * Pre-Approval Access : * Unlicensed : * Off-Label These regulatory programs are put in place on a country-by-country basis and can vary significantly across markets. == Geographic Differences == In the United States, the Food and Drug Administration (FDA) has sanctioned expanded access programs, which provide access to investigational drugs, since 1987. This access is typically offered in later stages of development, after earlier studies have established a relatively high degree of certainty in safety and effectiveness. FDA regulations define three types of access: : * ''Single-patient INDs'': a request from a physician to the FDA that an individual patient be allowed access to a drug : * ''Intermediate-size Patient Populations'': when the FDA receives a significant number of requests (about 10 to 100) for single-patient access to an investigational drug for the same use, they may ask the trial sponsor to consolidate these requests. : * ''Treatment INDs and Treatment Protocols'': access for a large number of patients who would not otherwise qualify for clinical trials In the European Union, named patient programs allow access to investigational drugs, as well as access to drugs approved in other countries but not yet in a patient’s home nation. For example, the programs allow patients to use drugs in the time period between centralized European Medicines Agency (EMA) approval and the launch in their home counties, a period which can range from one year to 18 months. Other countries implement other forms of MAPs. Canada uses “Special Access Programs” to provide access to non-marketed drugs to practitioners treating patients with serious illnesses when conventional therapies have failed, are unsuitable, or are unavailable. Australia provides patients access to experimental drugs via the “Special Access Scheme”, while Japan’s “Named Patient Access” makes drugs available if they are approved in the exporting nation. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Managed access program」の詳細全文を読む スポンサード リンク
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