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Post-Authorisation Safety Studies: Designing a PASS That Holds Up
A post-authorisation safety study is one of the few pharmacovigilance activities where a regulator reviews your methodology before you are allowed to begin. Get the[…]
Environmental Compliance for Medicines: The Revised ERA Guideline and the Wastewater Directive
The environment has become a regulatory obligation for pharmaceutical companies on two fronts at once. On one side sits the marketing authorisation dossier, where the[…]
Antimicrobial Resistance and the EU’s Search for Workable Incentives
Antimicrobial resistance is one of the most serious long-term threats to European health systems, yet the pipeline of new antibiotics has thinned to a trickle.[…]
Drug-Device Combination Products and Article 117 of the MDR: The Notified Body Opinion
Prefilled syringes, pens, autoinjectors and inhalers are medicines to their manufacturers and patients — but the device that delivers the dose has its own regulatory[…]
The GMP Annex 11 Revision: Computerised Systems, Data Integrity and the New AI Annex
EU GMP Annex 11, the rulebook for computerised systems in pharmaceutical manufacturing, dates from 2011 — before cloud computing, software-as-a-service and machine learning were part[…]
Market Access for Obesity Medicines in Europe: The Reimbursement Reckoning
The science of obesity treatment has raced ahead of the systems that pay for it. GLP-1 medicines have transformed clinical expectations, but across Europe reimbursement[…]
AI in the Medicines Lifecycle: What EU Regulators Now Expect
Artificial intelligence has moved from the margins of drug development into the mainstream of discovery, clinical trials, manufacturing and pharmacovigilance. EU regulators have responded with[…]
The EU Supply-Security Rulebook: Medicine Shortages, the ESMP and the Critical Medicines Act
Medicine supply security has become one of the most heavily regulated corners of EU pharmaceutical law — and one of the fastest-moving. Between Regulation (EU)[…]
GMP Inspection Readiness: Preparing Your Site for an EU Inspection
An EU good manufacturing practice (GMP) inspection is not an event to prepare for in the final weeks before an inspector arrives — it is[…]
The IVDR: Extended Deadlines, but No Room for Complacency
The In Vitro Diagnostic Regulation reshaped how diagnostics reach the EU market — and while transition deadlines have been extended, the conditions attached to them[…]