Regulatory Affairs
16 Oct 2026
CPHI Milan 2026: what we took away from three days in Milan
Our team spent three days at CPHI Milan. Here is what stood out and what it means for...
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Category
Regulatory Watch
MPCA's regulatory watch: the regulatory and legislative changes that matter for pharma, medical devices, supplements and cosmetics in the Benelux.
Regulatory Affairs
Regulatory Affairs
11 Aug 2026
CBG modernises its registration systems: what MAH holders need to know
The CBG-MEB is modernising its registration systems: new case numbers, digital signatures and submissions only via Common Repository...
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Regulatory Affairs
11 Aug 2026
Upcoming European healthcare legislation: are you ready?
Biotech Act, MDR/IVDR revision, Critical Medicines Act, new EU Pharmaceutical Legislation and stricter advertising rules: five initiatives to...
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GDP & Distribution
11 Aug 2026
Stock Monitoring Tool: draft royal decree approved, mandatory reporting is coming
On 18 July 2026 the Council of Ministers approved the draft royal decree introducing the Stock Monitoring Tool....
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GDP & Distribution
10 Aug 2026
Missed CAPA timelines: lessons from a recent GDP non-compliance case
A wholesaler was refused a GDP certificate after missing agreed CAPA deadlines. Why execution, not the plan, decides...
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Cosmetics
18 Jun 2026
New EU rules for food supplements and cosmetics: what is changing
Three EU regulatory changes for food supplements and cosmetics: harmonised nutrient levels, Belgian rules, and the Omnibus VIII...
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Medical Devices
11 Jun 2026
EUDAMED becomes mandatory from 28 May 2026: what to do now
From 28 May 2026 the first four EUDAMED modules become mandatory under MDR and IVDR. Here is what...
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Pharmacovigilance
11 Jun 2026
New GVP guidance for pregnant and breastfeeding women
The EMA has issued new GVP guidance on medicines used by pregnant and breastfeeding women. Here is what...
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Pharmacovigilance
11 Jun 2026
ICH E2D(R1): new standards for post-approval safety data
The revised ICH E2D(R1) guideline is now in effect in the EU. Here is what changes for post-approval...
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GDP & Distribution
11 Jun 2026
Stock Monitoring Tool: the 1 July go-live looks set to be postponed
An early heads-up: the FAMHP’s Stock Monitoring Tool, due to go live on 1 July 2026, looks set...
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