現地の専門性 · グローバルな実行力
この支援の対象
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
各国の規則を、貴社のグローバルモデルにつなげます。
Eunomia helps pharmaceutical and biotech teams plan US compliance operations, connecting federal and state requirements with review, engagement, monitoring and reporting workflows.
このサービスについて相談する
実務上の課題：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.
要件から実行へ
Eunomiaによる支援内容
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.
対応できる内容
製薬コンプライアンス：United States：支援範囲
現地コードの解釈と問い合わせ対応
医療従事者・患者団体との関わりのレビュー
現地の透明性・開示要件への対応
プロモーション資材・非プロモーション資材のレビュー
市場参入時のコンプライアンス評価
専門性と言語に関する要件の評価
このサービスで得られること
適用される要件（United States）をグローバルなプロセスに組み込み
レビューとエスカレーションの責任を明確化
不要な固定人員を抱えない現地サポート
各国の規則：United States
コンプライアンスを形づくるもの：United States…
主な法規制と自主規制の枠組みを簡潔にまとめたガイドです。各要約は、下記の公式情報にリンクしています。
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.
主な参照先
本概要は情報提供のみを目的としており、法的助言ではありません。適用範囲と適用方法は、対象となる組織、市場、活動および相手方について個別にご確認ください。情報源は2026年9月時点で確認しています。
よくあるご質問
製薬コンプライアンス：United Statesに関するよくあるご質問
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.
ご検討中の課題をお聞かせください。
お話を伺い、いくつか質問をしたうえで、適切な範囲をご提案します。義務や無理な勧誘はありません。
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