NDC(National Drug Code国家药品验证号)是药品作为普通商品的识别符号,由美国FDA定期编辑NDC系统索引,通过输入NDC号和注册信息作为进入药品注册列表系统(Drug Registration and Listing System,DRLS)数据库的程序,它包括了所有的处方药和部分经筛选的非处方药类药品。
根据1938年美国联邦法规(CFR)21卷下第201条款和1962年美国联邦法规21卷修改条例107(C)中的有关“Grandfather Clause”的条款,在这些法规实施前就已经上市的药品不作为新药管理,但要求其有效成分要重新得到FDA的认定,被认为是“Generally Recognized as Safe and Effective and Not Misbranded”。得到承认的成分由FDA公布,并附有剂量范围和主治功能。已经上市的任何OTC产品必须符合上述条件,否则按NDA新药申请处理。含有这些有效成分的药品可以直接申请NDC,并按OTC上市销售,不用申请NDA。目前,美国FDA准许在OTC中使用的有效成分有数百种,美国FDA对OTC的管理和成分的认定全部公布在Federal Register上,有关条款多达数10卷,几十万页,研究美国OTC的管理方法是专业律师和顾问所从事的专业工作,申请OTC的NDC号码必须需要对号入座。
▲ FEI is the Firm Establishment Identifier - FDA database is automatically generates a 10-digit FEI number when a new firm is added.
FEI是公司建立的识别符 – 当增加一个新公司的时候,FDA数据库自动生成一个10位数的FEI号。
Firm Establishment Identifier (FEI)
FACTS automatically generates a 10-digit FEI number under the firm build screen when a new firm is added. Firms previously in FIS retained their original 7-digit CFN which, in most cases, also became their FEI number. The old CFN can be viewed under the cross-reference viewing screen in FACTS. See Appendix IV, General Rules and Guidance for Assignment of Firm Establishment Identifiers, for assignment rules of FEI numbers.
▲Drug Establishment Registration and Product Listing
药厂注册和产品清单
▲FDA-2656
FDA-2657
▲Drug Product Listing Form 2657
药品清单表格2657
▲Drug Registration and Listing Introductions
药品注册和列表介绍
▲Drug Registration and Listing System 20060418
药品注册和列表系统 20060418
▲Drug Registration and Listing
药品注册和列表
▲Federal Register Final Rule Foreign Establishment Registration and Listing
国外药厂注册和列表的联邦注册法规
▲Guidance for Industry Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution 200104
工业指南 药品生产者注册和商业流通领域的药品清单 200104
▲Registration of Drug Establishment Labeler Code Assignment