Insights
Regulatory Affairs Insights
Current EU regulatory developments, AI in regulatory affairs, and practical analysis for pharmaceutical RA teams, grounded in official sources.
New to the field? Start with the EU regulatory affairs reading path.
Regulatory Updates
EMA is changing how SmPC section 5.1 is assessed. What should RA teams review before 2027?
On 19 October 2026 EMA published the CHMP's Methodological Principles for the Assessment of Section 5.1 of the SmPC (EMA/283093/2016), which come into effect on 1 January 2027. Section 5.1 should carry the confirmatory, clinically relevant and methodologically reliable results behind the authorised indication — usually the data cut where the hypothesis was rejected, one set of results per endpoint, no p-values. More data is not better product information.
EMA's first phased review reached a positive opinion. Is this the future of EU marketing authorisation?
On 15 October 2026 the CHMP recommended Rasonque (daraxonrasib) after EMA's first phased review, in which complete quality, non-clinical and clinical packages were assessed before the full application. The new EU Regulation will make phased review a standing option. A shorter assessment clock is not automatically a shorter regulatory programme: part of the work moves before Day 0.
The EU Biotech Act could rewrite clinical trial regulation. Is CTIS ready?
EMA says the clinical-trial changes in the proposed EU Biotech Act affect about 70% of current CTIS functionality. Work on a new CTIS platform starts in early 2027, a roadmap is due in December 2026, and the first new rules could apply in early 2028 — while Parliament and Council are still negotiating what those rules are. Simpler trials first mean a harder transition.
Annex II and the new master files: the EU dossier is getting modular, not simpler
The Council adopted the EU pharma package on 28 September 2026, and on 6 October the Pharmaceutical Committee discusses the first implementing work on dossier requirements and master files. The new Directive lets applicants rely on EMA-certified active substance, additional quality and platform technology master files. That cuts duplicate assessment. It also moves the hard part of regulatory work from writing the dossier to knowing what the dossier depends on.
EU variations in 2026: what changed and what regulatory affairs teams need to check
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 for
The EU is replacing the pharmaceutical framework it has worked under since 2004. Political agreement came in December 2025, the Council adopted it on 28 September 2026 and Parliament's vote is 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
How to research an EU regulatory question without being misled by AI
Fix the context first: product, procedure, member states and date. Then find the governing source, check that it is current and final, read the conditions around the passage, and verify every material claim against it — whether the claim came from a colleague, a consultant or an AI tool. AI is fast at finding and comparing candidate sources. It is unreliable at knowing which one applies today.
The regulatory affairs professional of the future: what humans should own and what AI agents should do
The future of regulatory affairs is not human versus AI. It is a better division of work. The agent should take on finding, checking, comparing, organising and monitoring regulatory information. The RA professional should spend that time interpreting evidence, deciding strategy and standing behind the outcome. Here is how we think the work should be split, and where the line must hold.
What is a regulatory affairs AI agent?
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
CMDh just updated MRP/DCP submission requirements. What should applicants check before their next procedure?
After its 13–14 October 2026 meeting, the CMDh updated the MRP/DCP validation advice, both compilations of national data requirements, the request form for an RMS in DCP, the MRP/RUP request form and the blue-box requirements. National requirements are now marked as validation or non-validation issues, a silent CMS can no longer hold a procedure indefinitely, and the RMS request form asks new questions about Article 10a, bioequivalence timing and ASMF numbers.
ePI is coming to EU medicines. But digitising product information won't fix bad regulatory data.
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.
eCTD v4.0 is coming. Why this is more than a submission format upgrade.
eCTD v4.0 has been optional for new centralised MAAs since 22 December 2025, is planned to be strongly recommended from Q1 2027 and mandatory for new CAP MAAs from Q1 2028. It replaces folder structure with identifiers, controlled vocabularies and document reuse — which makes it a regulatory data project, not a publishing upgrade.
AI Governance & Validation
Editorial standard: insights are prepared and reviewed internally against primary EU regulatory sources, with the sources used listed on every article and a review date that moves when the article is updated. Individual team member identities are not published.