Articles & insights
Regulatory Updates & Compliance News
New guidance, legislation and developments affecting pharmaceutical compliance.
The EU AI Act for Pharmaceutical Companies: What Applies and When
Explore EU AI Act requirements for pharma and biotech, including AI literacy, prohibited practices, high-risk uses and transparency obligations.
Read the article 2026-09-30Failure to Prevent Fraud: What Pharmaceutical Companies Need to Do
A pharma guide to the ECCTA failure to prevent fraud offence: organisations in scope, associated persons, base frauds and reasonable prevention procedures.
Read the article 2026-09-30Lessons from Recent PMCPA Cases: What 2026 Rulings Mean for Your Processes
Twelve PMCPA cases completed in 2026, summarised: social media, press releases, certification, prescribing information and culture, with practical fixes.
Read the article 2026-06-02PMCPA’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.
Read the article 2026-04-30Navigating 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.
Read the article 2026-02-23Sunshine 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.
Read the article 2025-09-04AI 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.
Read the article 2025-05-05The 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.
Read the articleQuestions, 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.