Current commentary.

Since 2024 WHO has listed the European regulatory network as a WHO Listed Authority – other regulators can rely on EU decisions. What this means for approvals outside the EU, and what the Council text of the Pharma Package provides.

No manufacturer change, stability question or safety signal starts in Regulatory Affairs – yet only the regulatory classification decides when the other functions may act. Why RA is the hub, and what the CMDh updated in autumn 2026.

eCTD v4.0 is becoming mandatory for new centralised marketing authorisation applications – currently planned from Q1 2028. Why this is not an IT project, and when MAHs should start.

With the reform, the environmental risk assessment becomes an ongoing obligation – including for older products that never had one. For antimicrobials, it reaches into manufacturing.

The annual grouping cycle for Type IA changes has been mandatory since 15 January 2026. The reform text adopted by the Council already sets out where it is heading — away from submissions, towards database updates.

Update of 1 October 2026: the Council's positions are formally with Parliament. The second reading now runs against a fixed deadline — and even without a vote, the package would be adopted once it expires.

On 28 September 2026, the Council formally adopted its positions on the new EU pharmaceutical legislation. Only Parliament is left — and that moves the realistic timeline.

The trilogue text is settled; the European Parliament's vote is indicatively scheduled for 23 November 2026. Six points are already solid enough to trigger program work.

On 1 October, WRPA opens for mandates. After more than twenty years in pharmaceutical regulatory affairs and programme management, I decided to bring both disciplines together in one place.