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The new EU clinical trials regulation aims at harmonization and transparency

European Union - October 20 2014 On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes…

Stephan Rau

New EU regulation on cosmetic products enters into force

European Union - July 12 2013 On 11 July 2013 Regulation (EC) No 1223/2009 (Regulation) will replace the Cosmetics Directive of 1976 that used to rule cosmetic products in the…

Sabine Naugès, Stephan Rau

EC introduces major changes to medical device regulation

European Union - December 17 2012 The European Commission has issued two proposals that, if approved, will fundamentally amend EU law on medical devices and in vitro diagnostics.

Kristian A. Werling

IFPMA releases revised code for interactions with health care professionals and other stakeholders

USA - March 16 2012 On March 1, 2012, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) issued a Code of Practice relating to interactions with the health care community, which replaces and expands upon its 2006 Code of Pharmaceutical Marketing Practices.

Glenn Engelmann, Susan S. Lee, Joan Polacheck