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News & insights

Pharmaceutical engineering insights for technical execution.

Original Cotectra thinking on engineering, delivery and asset reliability, together with selected updates from official industry sources.

Industry updates

Selected signals from primary sources.

External news is curated for relevance. Each link opens the original regulatory source.

External source

European Medicines Agency

1 July 2026

GMP workshop informs development of AI guidance for medicines manufacturing

EMA gathered expert input for the development of guidance on artificial intelligence in medicines manufacturing under Annex 22.

External source

U.S. Food and Drug Administration

1 February 2026

FDA PreCheck Pilot Program for pharmaceutical manufacturing facilities

The pilot introduces earlier engagement around facility readiness and manufacturing-site assessment before a specific product application.

External source

European Medicines Agency

Updated June 2026

EU pharmaceutical legislation reform remains an active regulatory topic

EMA's current updates provide access to the evolving reform context and related regulatory information.

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