新药研发主办人（Pharmaceutical R&D Sponsor）

美国FDA关于新药研发主办人（Drug Sponsor）

http://www.fda.gov/cder/handbook/sponsor.htm

Applicant (Drug Sponsor)

An applicant, or drug sponsor, is the person or entity who assumes responsibility for the marketing of a new drug, including responsibility for compliance with applicable provisions of the Federal Food, Drug, and Cosmetic Act and related regulations. The "sponsor" is usually an individual, partnership, corporation, government agency, manufacturer or scientific institution.

这就意味着所有上市新药（专利有效期内并有合法商品名的药品），如果被发现任何问题，新药研发主办人（Pharmaceutical R&D Sponsor）（Drug Sponsor）将受到极其严厉、残酷的经济制裁甚至刑事处罚。这就要求所有新药研发主办人（Pharmaceutical R&D Sponsor）（Drug Sponsor）都必须具备：对所研发药品的整体性的正确认识，对所研发药品研发过程的整体性的正确认识，对所研发药品涉及疾病的整体性的正确认识。在美国，新药研发相关的设计监理费用约占新药总研发成本的三分之一，这也与新药研发主办人（Pharmaceutical R&D Sponsor）（Drug Sponsor）所承担的沉重责任密切相关。

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