Category: Pharma

Agreement between the EEA Heads of Medicines Agencies and the Pharmaceutical Inspection Co-operation Scheme

The Heads of Medicines Agencies of the European Economic Area (EEA HMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) signed a Letter of Agreement. The objective of the agreement is the exchange of information after audits among authorities and joint training for GxP inspectors. The agreement came into force August 2016.

MedTech Europe help for Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

The “Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union” …

KOMUNIKAT KOMISJI Wytyczne w sprawie przyjęcia odstępstw ogólnounijnych dotyczących wyrobów medycznych zgodnie z art. 59 rozporządzenia (UE) 2017/745

Rozporządzenie Parlamentu Europejskiego i Rady (UE) 2017/745 w sprawie wyrobów medycznych przyjęto dnia 5 kwietnia 2017 …

EMA warns against using unproven cell-based therapies

EMA’s Committee for Advanced Therapies (CAT) is advising patients and the general public against using unregulated cell-based …