In 2016 the new regulation 536/2014 EC will become effective. It will replace the current Directive 2001/20 about clinical trials. The document can be downloaded on the official site of the EU. If you will read through the document you will see that there are quite some changes, which will impact the current annex 13 and annex 16 to the EU GMP vol 4 guidelines. The so-called green light has been removed from the procedure, while this is a well-known saying among QPs. Would the coming effective of this guidline also delay the update of the new annex 16? It might well be. Fortunately there is a correlation table in the back of document, which referes the old article numbers to the new numbers. But even with this I found it quite difficult to find where it is written that a green light should be obtained before commencing a clinical trial.

May be more discussions about this will arise in the coming year. I will try to keep you posted in this.