I'm trying to obtain from Health Canada the right procedure to submit a Clinical Trial Application (CTA) in order to initiate a "first in human" trial with a new radiopharmaceutical compound (PET imaging). Apparently, there is a non-enforcement agreement allowing independent scientists to use a procedure different from the one required by the big pharmas to obtain such a CTA approval. However, there is no specific information on their web site, and trying to reach the good person at this place is a real nightmare. I was wondering whether any of you could help me in finding the right path. Any help or contact would be most appreciated in this respect.