如何注册药品生产企业
正文 · 中文译文
如何注册药品生产企业 药品注册与列名说明 如何注册药品生产企业 如何申请标签商代码 如何预留国家药品代码 如何列名药品 从事生产、重新包装、重新贴标或回收药品以供美国分销的企业，除某些豁免情况外，均须向FDA注册。只有被要求向FDA注册的企业才应进行注册。 何时注册 美国境内的企业须在将药品引入商业分销后五天内完成注册。美国境外的企业必须在药品被提供进口之前完成注册。 企业须在每年10月1日至12月31日之间续展其注册。 注册流程 创建并提交企业注册结构化产品标签（SPL）文件以向FDA注册。该机构建议企业保存其提交文件的副本。请记得包括： 企业名称及邓白氏验证码或数据通用编号系统（DUNS）编号（不得使用与公司总部关联的编号） 负责接收FDA与该企业相关通信的人员的联系信息 该企业执行的所有适用业务操作 对于境外企业，美国代理人的名称和DUNS编号以及所有进口商的名称和DUNS编号 有关更多信息，请访问使用FDA Direct注册企业的说明（第三页）。 无变更的续展或更新 使用 FDA Direct 提交无变更通知：打开先前已提交并接受的机构注册 点击创建新版本 将文档类型更改为无变更通知 提交 SPL 访问使用 FDA Direct 提交无变更通知提交的分步说明。 使用其他应用程序提交无变更通知：创建无变更通知 SPL 文档 在 set ID 中填写先前或最近一次提交中的值 输入适当的生效日期和版本号（通常比先前提交的版本号高一位） 提交 SPL 更新机构注册信息 使用 FDA Direct 提交变更：打开先前已提交并接受的机构注册 点击创建新版本 输入需要更新的新地址/DUNS 或联系信息 提交 SPL 访问使用 FDA Direct 更新机构注册的说明（第 13 页）以获取更多信息。 使用其他应用程序提交变更：创建最近一次提交的副本/新版本 不要更改 set ID。保留先前版本中的原始 set ID 生成新的文档 ID/根 ID 输入适当的生效日期和版本号（通常比先前提交的版本号高一位） 视情况修改所有机构和联系信息 提交 SPL 注销或提交停业通知 使用 FDA Direct 注销：打开先前已提交并接受的机构注册 SPL 点击创建新版本 根据需要将文档类型更改为机构注销登记或停业通知，并提交SPL 访问“注销机构登记并使用FDA Direct提交停业通知的说明”（第23页）以获取更多信息。 使用其他应用程序进行注销：创建机构注销登记SPL文档 在设置ID中填写上一次提交时的设置ID 输入适当的生效日期和版本号（通常比上一次提交的版本号高一个数字） 提交SPL 检查注册状态 在药品机构当前注册站点（DECRS）查找注册状态。成功提交注册后，公司名称和信息将在下一个工作日结束前出现在该站点上。列表将显示到期日期为次年12月31日。 访问“药品注册和列表说明”以获取如何向FDA列出药品的说明。 内容截至日期： 2026年8月3日 受监管产品 药品
正文 · 英文原文
How to Register a Drug Establishment Drug Registration and Listing Instructions How to Register a Drug Establishment How to Request a Labeler Code How to Reserve a National Drug Code How to List a Drug Establishments, with certain exemptions, engaged in manufacturing, repacking, relabeling or salvaging drugs for U.S. distribution are required to register with FDA. Only establishments required to register with FDA should do so. When to register Establishments in the U.S. are required to register within five days of introducing drugs into commercial distribution. Establishments outside of the U.S. must complete registration prior to the drug being offered for import. Establishments must renew their registration between October 1 and December 31 each year. Registration process Create and submit an establishment registration structured product labeling (SPL) document to register with FDA. The agency recommends establishments save a copy of their submission. Remember to include: The name and Dun and Bradstreet verification, or Data Universal Numbering System (DUNS) number of the establishment (not one linked to the corporate headquarters) Contact information of someone responsible for receiving FDA communications related to that establishment All applicable business operations that establishment performs For foreign establishments, the name and DUNS of a U.S. agent and all importers Visit instructions for registering an establishment using FDA Direct (page three) for more information. Renew or update with no changes To submit no change notification using FDA Direct:Open the previously submitted and accepted establishment registration Click create new version Change the document type to no change notification Submit SPL Visit step-by-step instructions on submitting a no change notification submission using FDA Direct. To submit a no change notification using other applications:Create a no changes notification SPL document Fill in the set ID with the value from the previous or most recent submission Enter the appropriate effective date and version number (generally, one number higher than the previous submission) Submit SPL Update establishment registration information To submit a change using FDA Direct:Open the previously submitted and accepted establishment registration Click create new version Enter the new address/DUNS or contact information that needs to be updated Submit SPL Visit instructions to update establishment registration using FDA Direct (page 13) for more information. To submit a change using other applications: Create a copy/new version of the most recent submission Do not change the set ID. Retain the original set ID from the previous version Generate a new document ID/root ID Enter an appropriate effective date and version number (generally, one number higher than the previous submission) Modify all establishment and contact information as appropriate Submit SPL De-register or submit an out of business notification To de-register using FDA Direct: Open the previously submitted and accepted Establishment Registration SPL Click create new version Change the document type to establishment de-registration or out of business notification as appropriate and submit SPL Visit Instructions to de-register an establishment and submit an out of business notification using FDA Direct (page 23) for more information. To de-register using another application: Create an establishment deregistration SPL document Fill in the set ID with the set ID from the previous submission Enter the appropriate effective date and version number (generally, one number higher than the previous submission) Submit SPL Check registration status Find registration status at drug establishment current registration site (DECRS). After successfully submitting the registration, the company’s name and information will appear on the site by the end of next business day. The listing will show an expiration date of December 31 of the following year. Visit Drug Registration and Listing Instructions for instructions on how to list drugs with FDA. Content current as of: 08/03/2026 Regulated Product(s) Drugs