本地专业知识 · 全球交付
本项支持适用对象
For international pharma teams preparing US commercial activity, emerging biotechs building compliance processes and compliance leaders coordinating multiple states, products and third parties.
Pharmaceutical compliance support in the United States
本地规则，与您的全球模式相衔接。
Eunomia helps pharmaceutical and biotech teams plan US compliance operations, connecting federal and state requirements with review, engagement, monitoring and reporting workflows.
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实际挑战：United States
US requirements span federal law, FDA rules, programme integrity, transparency reporting, industry commitments and state laws. A national SOP may miss state-specific reporting, marketing-code or HCP interaction requirements.
从要求到行动
Eunomia 如何提供帮助
We can map planned activities to applicable requirements, identify state-specific questions for legal review and translate agreed controls into SOPs, approval routes and monitoring. Support can include promotional review coordination, HCP engagement and payment workflows, reporting checks, training and automation. Eunomia identifies Karen Glade as its Global Compliance Business Partner for the United States and Canada; confirm scope and specialist support before engagement.
我们可承接的工作
制药合规：United States：支持范围
本地行业准则解读与问题处理
医疗卫生专业人士及患者组织合作事项审查
本地透明度与披露要求
推广和非推广材料审查
市场准入合规评估
专业能力与语言要求评估
服务带来的价值
适用要求（United States）融入您的全球流程
明确审查与升级处理的职责
本地支持，无需增加不必要的固定人员
规则：United States
合规的决定因素：United States…
主要法律和行业自律框架的简要指南。每项摘要均附有下方的官方来源链接。
FDA prescription drug promotion
FDA rules require advertising to be truthful and non-misleading, with risk information in fair balance with benefit claims. Claims must be consistent with approved labeling and supported by appropriate evidence. Build review, reference checks, version control and applicable submissions into the workflow.
Consumer health claims
FTC guidance requires health-related advertising claims to be truthful, not misleading and adequately substantiated before dissemination. Review campaign net impression, including digital content, testimonials and implied claims, and retain supporting evidence.
Federal HCP arrangements
The federal Anti-Kickback Statute prohibits knowingly and willfully offering, paying, soliciting or receiving remuneration to induce or reward referrals involving items or services payable by a federal healthcare programme. Assess arrangements on their facts; written terms, legitimate need, appropriate compensation and evidence of services are useful controls. Obtain legal advice where required.
Open Payments
Applicable manufacturers and group purchasing organisations report specified payments to covered recipients and certain physician ownership interests through CMS Open Payments. Applicability depends on statutory definitions. Build recipient validation, reconciliation, correction, attestation and records into the annual process; CMS thresholds change each year.
Industry codes and state requirements
The PhRMA Code is an industry commitment for companies that adopt it, not a federal statute. States may add conduct, registration, training, audit or disclosure obligations. Massachusetts, for example, requires covered manufacturers to register, follow its marketing code, train relevant staff, conduct annual audits and submit reports. Maintain a state-by-state assessment.
主要参考资料
本概述仅供参考，不构成法律意见。具体适用范围和适用方式，应结合相关机构、市场、活动和交易对方予以确认。信息来源核查于 2026 年 9 月。
常见问题解答
制药合规：United States常见问题
Does FDA pre-approve every US promotional material?
No. FDA says pre-approval is generally not required, subject to limited exceptions and specific requirements. Companies remain responsible for compliant content and applicable submissions.
Does one federal process cover every state?
No. States may impose additional conduct, registration, training, audit or disclosure rules. Assess states where the company, agents and activities operate.
Does Eunomia have a US office or formal regulatory representative?
This guide does not claim a US office or formal regulatory appointment. Eunomia identifies Karen Glade as its Global Compliance Business Partner for the United States and Canada. Contact us to confirm expertise and delivery arrangements.
请告诉我们您手头的工作。
我们会认真倾听、了解情况，并推荐合适的服务范围，无需承诺，也没有压力。
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