Posts from 17 Ιουλίου, 2026

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 is the single biggest commercial variable in the Greek pharmaceutical market. The rules for the rest of this decade were quietly rewritten in late[…]

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 designation is one of the most valuable regulatory assets in Europe — and the rules that govern it are about to change for the[…]

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[…]

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[…]

A medicine can be manufactured perfectly and still reach the patient compromised. Good Distribution Practice governs everything that happens in between — and it is[…]

The revised Annex 1 did more than tighten sterile manufacturing rules — it made the Contamination Control Strategy the organising document of your entire quality[…]

The EU variations framework has just been through its most significant revision in over a decade — and the rules changed on a different date[…]

An eCTD dossier can be scientifically flawless and still fail at the door. Most submission delays are technical, not clinical — and nearly all of[…]