Insights

Regulatory Affairs Insights

Current EU regulatory developments, AI in regulatory affairs, and practical analysis for pharmaceutical RA teams, grounded in official sources.

Regulatory Updates

EU variations in 2026: what changed and what regulatory affairs teams need to check17 September 2026 · The revised Variations Regulation has applied since 1 January 2025. The new Commission Variations Guidelines have applied since 15 January 2026. New classification codes, transition rules, Type IA annual-update cycles and updated submission tooling are now part of everyday work rather than a future change.EU pharmaceutical legislation reform 2026: what regulatory affairs teams need to prepare for17 September 2026 · The EU is replacing the pharmaceutical framework it has worked under since 2004. Political agreement came in December 2025, formal adoption is still pending, and a transition period to 2028 is planned while the Commission, EMA and national authorities build the rules, guidance, procedures and systems. For RA teams, implementation has started before the law is in the Official Journal.

AI in Regulatory Affairs

What is a regulatory affairs AI agent?17 September 2026 · A regulatory affairs AI agent is not a chatbot with a pharma prompt. What the term should mean, what such an agent can do today, and where the human decision starts.

Regulatory Operations

ePI is coming to EU medicines. But digitising product information won't fix bad regulatory data.17 September 2026 · Electronic product information turns the SmPC, package leaflet and labelling from documents into structured regulatory data. That is a real improvement — and it means errors, inconsistencies and weak data governance become machine-readable too. FHIR can structure information. It cannot tell us whether the information is correct.

AI Governance & Validation

Why hallucinated citations are a serious problem in regulatory affairs AI17 September 2026 · In regulatory work a citation is the audit trail. The ways AI citations go wrong, why RA is unusually exposed, and the checks that catch them.