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Focus on Regulation

Tag Archives: guidelines

New EU draft guidelines on clinical trials with ATMPs open for consultation

The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft guidelines (the “Guidelines”) governing good clinical practice specific to advanced therapy medicinal products (“ATMPs”). The purpose of the Guidelines is to adapt existing good clinical practice rules (“GCPs”) to ATMPs. This step

De-Regulating the Sharing Economy: European Commission Publishes Guidelines to Promote National Harmonization

Back in October 2015, as part of its Single Market Strategy, the European Commission declared that it would develop an agenda to encourage consumers, businesses and public authorities to engage confidently in the sharing economy (also known as the “collaborative economy”), where private individuals provide on-demand services to other people, without intermediaries. This peer-to-peer model

EDQM Publishes Draft Guidelines on Endotoxins, Pyrogens and Sterile Products

The European Directorate for the Quality of Medicines (“EDQM”) has published draft revisions to its Guidelines for Using the Test for Bacterial Endotoxins. Bacterial endotoxins are contaminants from gram-negative bacteria and are the most common cause of pyrogenicity in pharmaceutical products. The EDQM Guidelines explain the justifications for the requirements in the test for bacterial