Category: GLP

Draft Guidance Documents on GLP for public comments

The Organisation for Economic Co-operation and Development (OECD) published draft GLP document on the management, characterisation and use of tested items. The document is designed to provide guidance on: the transportation, identity, receipt, handling, storage, archiving and disposal of all test items used on GLP studies. Test items include agrochemicals, industrial chemicals, pharmaceuticals and biological agents (vaccine, antibody, enzyme, etc.). The scope of the guidance also covers formulated test items and medical devices.

Deadline for comments – 22 June 2017

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 …