Two long-running transitions landed in the third quarter of 2025.
E6(R3) applicable in the EU
From 23 July 2025 the European Medicines Agency applies ICH E6(R3) to clinical trials, with the principles and Annex 1 replacing E6(R2). Sponsors running EU studies should have updated monitoring plans, data governance procedures and vendor oversight to the new structure; inspectors will reference the new text.
FDA Computer Software Assurance guidance finalised
FDA issued the final CSA guidance for production and quality system software in September 2025, three years after the draft. The final version keeps the risk-based model: identify intended use, assess process risk, select proportionate assurance activities, and record the rationale and results. Our earlier summary of the approach is here.
Combined effect
Both documents reward teams that can explain why they did what they did. The skills in demand are risk assessment, clear documentation and the ability to defend a proportionate approach, not the ability to generate volume. Vakula's validation and monitoring practices have been recruiting for exactly those profiles.