Regulatory updates

Annex 1: the Contamination Control Strategy is no longer optional

The revised Annex 1 of the EU GMP requires every sterile manufacturer to maintain a documented, cross-functional and living Contamination Control Strategy (CCS): not a one-off report, but a system connecting facility design, personnel qualification, aseptic process simulations and barrier technologies (RABS, isolators).

AEMPS and EMA inspections now request it systematically, and a merely formal CCS is one of today's most repeated findings. It pays to audit it against real monitoring data, not just against the text of the rule.

Reform of EU pharmaceutical legislation: the biggest in twenty years

The Commission's proposal (April 2023) will replace Directive 2001/83/EC and Regulation 726/2004: incentives conditional on launching in all Member States, measures against shortages and modulated regulatory protection. Parliament adopted its position in April 2024 and the text is still being negotiated between the institutions.

Although the final text will take time to apply, the registration and lifecycle decisions taken today will live under that framework — it belongs in your strategic planning now.

Clinical Trials Regulation: CTIS is now the only channel

With the transition period over, since 31 January 2025 all clinical trials in the EU are governed by Regulation (EU) 536/2014 and managed through the single CTIS portal: application, coordinated assessment across Member States and publication under the new transparency rules.

For sponsors used to the previous regime, the change affects timelines, documentation and data confidentiality: reviewing internal procedures avoids surprises on the first multinational application.

Nitrosamines: from one-off crisis to continuous vigilance

The EMA/CMDh framework consolidated the three-step cycle — risk evaluation, confirmatory testing and mitigation — and the CPCA approach for setting limits for API-related nitrosamines (NDSRIs). The key point: it is no longer a closed exercise but a living obligation of the marketing authorisation holder.

Any change of supplier, process or packaging material triggers a re-evaluation. Keeping assessments current and traceable is what distinguishes a solid dossier at inspection today.

ICH Q9(R1): risk management with less subjectivity

The revision of the quality risk management guideline tackles its historical weaknesses: subjectivity in assessments, formality disproportionate to actual risk and decisions poorly grounded in data. It also introduces product availability risk as an explicit concern.

Inspectors now expect more mature QRM systems: fewer decorative colour matrices and more justified decisions. It is a good moment to audit the real quality of the risk exercises in your quality system.

Tell us about your case

These briefings are informative and do not replace an analysis of your specific situation. If any of them touches your business — or you would like us to assess its impact — write to us and we will reply within 24 working hours.