Post by
Derby44 on Dec 12, 2017 12:36pm
Reply from TBP on Facebook about Dec 9 news
Health Canada is asking us to switch 2 steps of the submission process. Usually, the GMP certification is evaluated after the phase 3 clinical trial for a drug. As this this the first cannabis phase 3 trial and the active ingredient (API) is a plant, OCT (Office of Clinical Trials) recognizes they are outside of the regulations. They want to make sure of the quality of our API, so Health Canada will assess Aphria's operations for Good Manufacturing Practices (GMP) for pharmaceutical products before the beginning of the phase 3 instead. As those 2 steps had to take place for the DIN submission anyway, this should not affect our time to market for PPP001.
This is actually good news because it ensures the quality and safety of our product for patients and a GMP certification should reassure doctors who are reluctant prescribing cannabis.