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Regulatory Updates & Compliance News

New guidance, legislation and developments affecting pharmaceutical compliance.

2026-06-02

PMCPA’s 2026 Social Media Guidance: Compliance Priorities Companies Should Address Now

What the PMCPA's 2026 Social Media Guidance means for pharma: employee activity, corporate accounts, influencers and adverse event monitoring.

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2026-04-30

Navigating Country-Level Accountability in Europe: A Key Pillar of Healthcare Compliance

How legal representative and national compliance roles differ across Spain, France and Germany, and how to fit them into your global governance.

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2026-02-23

Sunshine Act in France: Understanding the Transparency in Healthcare System

The French Sunshine Act (Loi Bertrand) explained: who must report, what is published on Transparence Santé, timelines, penalties and EFPIA differences.

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2025-09-04

AI in Healthcare Compliance: Navigating Opportunities, Risks, and Regulatory Landscapes

How AI supports pharma compliance audits, material review and regulatory monitoring, the risks of bias and over-reliance, and what the EU AI Act means.

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2025-05-05

The Future of Diversity & Inclusion in Pharma Compliance: A European Perspective

Diversity and inclusion in pharma compliance from a European perspective: why DEI remains a compliance matter and how to embed it in governance.

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Questions, answered

Regulatory Updates & Compliance News: common questions

What is the UK failure to prevent fraud offence?

A corporate offence introduced by the Economic Crime and Corporate Transparency Act 2023, which has applied since 1 September 2025.

Which EU regulation governs AI?

Regulation (EU) 2024/1689, the EU AI Act, read alongside the GDPR, the EU Data Act and, where AI forms part of a medical device or diagnostic, the MDR and IVDR.