Which upcoming EU regulatory changes concern your product?

Set your product profile above to see whether this programme concerns your product, and why.

The amended Variations Regulation (Regulation (EC) No 1234/2008) has applied since 1 January 2025. The revised Variations Guidelines (C/2025/5045) apply to variations submitted from 15 January 2026, together with the updated electronic application form (eAF).

No further change to the framework itself is scheduled. EMA and CMDh procedural guidance and Q&A on the revised framework continue to be updated.

Applicable: A current requirement that applies today.

• 1 January 2025 Amended Variations Regulation becomes applicable Confirmed
• 15 January 2026 Revised Variations Guidelines and updated eAF apply to new submissions Confirmed

• Further updates to EMA and CMDh procedural guidance and Q&A on the revised framework.
• How changes not listed in the guidelines will be classified case by case.

• EMA — Guidance on the application of the revised variations framework
• Commission Guidelines (C/2025/5045) on the details of the various categories of variations
• Consolidated Regulation (EC) No 1234/2008 — Examination of variations to the terms of marketing authorisations (01 January 2025)

• EMA's page on applying the revised variations framework.
• CMDh procedural guidance and eAF release notes.

• whether planned changes are classified under the 2025 guidelines (C/2025/5045), not the 2013 guidelines.
• variation SOPs and templates that still reference the previous classification categories.

Set your product profile above to see whether this programme concerns your product, and why.

eCTD v3.2.2 remains accepted during the transition. Since 22 December 2025, new marketing authorisation applications for centrally authorised products may optionally be submitted in eCTD v4.0.

EMA plans strongly recommended use of eCTD v4.0 for new CAP marketing authorisation applications from Q1 2027, and mandatory use for new CAP applications from Q1 2028. Both dates are planned, not confirmed.

Phased: Applies in stages, by procedure, product group or date.

• 22 December 2025 Optional eCTD v4.0 use for new CAP applications Confirmed
• 15 July 2026 Updated eCTD v4.0 validation criteria applicable Confirmed
• H2 2026 Technical pilot for new non-CAP applications planned to start (Q3/Q4 2026) Indicative
• Q4 2026 New forward-compatibility pilot phase for CAPs planned Indicative
• Q1 2027 Strongly recommended use for new CAP applications planned Indicative
• Q1 2028 Mandatory use for new CAP applications planned Indicative

• When existing v3.2.2 lifecycles can move to v4.0. EMA says forward compatibility depends on testing and further readiness assessments.
• Rollout dates for MRP, DCP and national procedures.
• Whether the planned Q1 2027 and Q1 2028 dates hold.

• EMA eCTD v4.0 — implementation timeline, pilots and technical documentation
• EU eCTD v4.0 Practical Guidance v1 — CAP marketing authorisation applications

• EMA's eSubmission eCTD v4.0 page for updated dates.
• Results of the CAP forward-compatibility pilot phase planned for Q4 2026.
• National competent authority announcements on the non-CAP pilot.

• whether your publishing tool supports EU eCTD v4.0 and has been tested end to end.
• SOP steps written for eCTD v3.2.2 lifecycle handling.

Set your product profile above to see whether this programme concerns your product, and why.

Product information is still submitted as Word or PDF annexes in eCTD. EMA's guidance on ePI submission for centrally authorised medicines (EMA/199350/2026, published 4 September 2026) becomes applicable at ePI go-live.

EMA's draft roadmap (March 2026) plans a voluntary, phased go-live for centrally authorised products from Q4 2026: vaccines first, then oncology products, then other therapeutic areas. Plans for nationally authorised products follow a readiness assessment with national authorities.

Phased: Applies in stages, by procedure, product group or date.

• 4 September 2026 EMA publishes ePI submission guidance for centrally authorised medicines Confirmed
• Q4 2026 Voluntary ePI go-live planned for vaccines (ATC J07) Indicative
• 2027 Voluntary go-live planned for oncology products, then all CAPs Indicative

• The exact ePI go-live date.
• When ePI becomes mandatory. EMA links this to the new pharmaceutical legislation.
• Timelines for nationally authorised products (MRP, DCP and national).

• EMA — Electronic product information (ePI) for human medicines
• EMA — Electronic product information (ePI) implementation roadmap (draft, March 2026)

• EMA's ePI page and the final roadmap.
• National competent authority announcements on national ePI rollout.
• PLM portal release notes for ePI authoring.

• who will author ePI in the PLM portal alongside the Word or PDF annexes.
• whether your product's therapeutic area is in an early go-live group.

Set your product profile above to see whether this programme concerns your product, and why.

Directive 2001/83/EC and Regulation (EC) No 726/2004 remain the governing EU legislation for human medicines.

The European Parliament and the Council reached political agreement on the reform on 11 December 2025. EMA expects the new acts to enter into force in 2026 and to become applicable in 2028, after a transition period.

Legislative finalisation: Agreed politically. Formal adoption and publication are still pending.

• 11 December 2025 Political agreement between the European Parliament and the Council Confirmed
• 2026 Entry into force expected (EMA) Indicative
• 2028 Expected to become applicable after a transition period (EMA) Indicative

• The date of publication in the Official Journal of the European Union.
• The final legal text, article numbering and transitional provisions.
• The content and timing of the implementing and delegated acts.

• EMA — Reform of the EU pharmaceutical legislation
• Directive 2001/83/EC — Community code relating to medicinal products for human use
• Regulation (EC) No 726/2004 — Community authorisation and supervision of medicinal products; establishing the EMA

• Publication of the final acts in the Official Journal.
• EMA's reform page and its implementation timeline.
• Commission implementing and delegated acts during the transition period.

• which planned procedures fall in the 2026 to 2028 transition window.
• who on your team will track the final legal text once it is published.