Real-World Evidence in EU Medicines Regulation: From Nice-to-Have to Core
Real-world evidence (RWE) has moved from the margins of EU medicines regulation to its core. Through initiatives such as DARWIN EU, the European Medicines Agency[…]
External Reference Pricing in Greece: How Prices Are Set and Reviewed
External reference pricing (ERP) sits at the heart of how medicine prices are set in Greece. For any company launching a product, understanding how the[…]
The Pharmacovigilance System Master File: The First Document an Inspector Asks For
The pharmacovigilance system master file (PSMF) is the single document that describes how a marketing authorisation holder runs its safety system — and it is[…]
The EU Pharma Package: A New Baseline for Exclusivity and Access
After more than two years of negotiation, the European Union has settled the text of its new pharmaceutical legislation — the most significant overhaul of[…]
EU MDR: Transition Deadlines and the EUDAMED Shift
The medical device transition has moved from a cliff edge to a staged runway — but the conditions attached to those extensions have already passed,[…]
Clawback and Rebates in Greece: The 2026-2030 Framework
Clawback is the single biggest commercial variable in the Greek pharmaceutical market. The rules for the rest of this decade were quietly rewritten in late[…]
Managed Entry Agreements: Sharing Risk in Greece
When a payer cannot be certain a medicine is worth its price, the answer is increasingly not “no” — it is a contract that shares[…]
Orphan Drug Designation in the EU: Framework and Reform
Orphan designation is one of the most valuable regulatory assets in Europe — and the rules that govern it are about to change for the[…]
Risk Management Plans: Structure and Substance
A Risk Management Plan is not a formality appended to a dossier. It is the document in which you commit, in writing, to how a[…]
PSURs: Getting the Periodic Safety Update Right
The Periodic Safety Update Report is where a product’s benefit-risk balance is formally re-argued. Miss the deadline or the format, and a routine obligation becomes[…]