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 entering Canada, emerging biotechs preparing commercial activity and compliance leaders coordinating federal rules, provincial health systems and English and French materials.
Pharmaceutical compliance support in Canada
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 Canadian compliance operations, connecting federal advertising requirements and industry commitments with provincial context, bilingual review planning and HCP engagement controls.
このサービスについて相談する
実務上の課題：Canada
Canada combines federal regulation of health product advertising with industry-code commitments, provincial and territorial rules, professional standards and institutional policies. Prescription drug advertising to the public is tightly restricted; Quebec has distinct French-language requirements.
要件から実行へ
Eunomiaによる支援内容
We can scope a market-readiness review, map activities to federal rules and applicable code commitments, and identify provincial, French-language or specialist questions requiring local review. Outputs can include a responsibility matrix, promotional workflow, HCP engagement and payment controls, disclosure checks, monitoring plan and action list. 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：Canada：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（Canada）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：Canada
コンプライアンスを形づくるもの：Canada…
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。
Federal advertising rules
The Food and Drugs Act and Regulations govern health product advertising. Health Canada states public prescription drug advertising is generally restricted to the drug's brand, proper or common name, price and quantity; further restrictions apply to certain diseases and products. HCP advertising is treated differently but remains subject to federal requirements.
Authorized products and claims
Promotion is generally limited to products authorized for sale in Canada and must respect the terms of market authorization. Health Canada guidance distinguishes advertising from other activities, including scientific or medical information. Review purpose, audience, content and context before classifying digital, social, investor or disease-awareness communications.
PAAB preclearance
The PAAB Code sets standards for advertising within its scope, including full, fair and balanced disclosure. Preclearance is a Code requirement for in-scope materials unless exempt; it is not universal statutory pre-approval. Health Canada can require preclearance in defined circumstances. Confirm the applicable route, language and review status.
Innovative Medicines Canada Code
The IMC Code guides member-company activities in commercializing prescription medicines. It is an industry commitment, not legislation automatically binding every company. Confirm membership or contractual adoption and translate applicable requirements into engagement, sponsorship, meal, education and review controls.
Transparency and provincial variation
Canada has no single federal HCP payment register equivalent to US Open Payments. IMC publishes a voluntary disclosure framework for participating companies. Check provincial requirements separately: Ontario's enacted Health Sector Payment Transparency Act states that it comes into force on a date set by proclamation; verify current status before treating it as operative.
Quebec language requirements
Health professional rules, privacy requirements and institution policies vary by province and territory. Quebec's Charter of the French Language requires commercial advertising to be in French; where another language is used, French must generally be markedly predominant, subject to exceptions. Plan French-language review and confirm application to each product, channel and audience.
主な参照先
Health Canada: Advertising requirementsHealth Canada: Prescription drug marketingHealth Canada: Advertising and other activities guidanceHealth Canada: Advertising preclearancePAAB Code of Advertising AcceptanceIMC: Code of Ethical PracticesIMC: Voluntary disclosure frameworkOntario: Health Sector Payment Transparency ActQuebec: Charter of the French Language, section 58
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：Canadaに関するよくあるご質問
Can prescription medicines be advertised to the public in Canada?
Federal law generally restricts public prescription drug advertising to the brand, proper or common name, price and quantity. Disease and product-specific restrictions also apply.
Is PAAB preclearance required for every promotion?
No. It is a Code requirement for materials within the PAAB Code's scope unless exempt. Health Canada may require preclearance in defined cases.
Is there one federal database for HCP payments?
There is no single federal HCP payment register equivalent to US Open Payments. IMC has a voluntary framework; provincial laws and status should be assessed separately. Ontario's 2017 Act says commencement is by proclamation.
Does Eunomia have a Canadian office or formal regulatory representative?
This guide does not claim a Canadian 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, French-language support 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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