Expert perspectives from the M.P.C.A. International team on Regulatory Affairs, Pharmacovigilance, GMP/GDP and market access in the Benelux.
Featured
The CBG-MEB is modernising its registration systems: new case numbers, digital signatures and submissions only via Common Repository or CESP. What applicants need to do.
Read full article
Regulatory Affairs
Biotech Act, MDR/IVDR revision, Critical Medicines Act, new EU Pharmaceutical Legislation and stricter advertising rules: five initiatives to...
GDP & Distribution
On 18 July 2026 the Council of Ministers approved the draft royal decree introducing the Stock Monitoring Tool....
GDP & Distribution
A wholesaler was refused a GDP certificate after missing agreed CAPA deadlines. Why execution, not the plan, decides...
Cosmetics
Three EU regulatory changes for food supplements and cosmetics: harmonised nutrient levels, Belgian rules, and the Omnibus VIII...
Medical Devices
From 28 May 2026 the first four EUDAMED modules become mandatory under MDR and IVDR. Here is what...
Pharmacovigilance
The revised ICH E2D(R1) guideline is now in effect in the EU. Here is what changes for post-approval...
Our team of specialists is ready to support you — from regulatory strategy and pharmacovigilance to market access and quality assurance.