Update on the status of TCM Herbal medicines

submitted by ATCMA member Dr. John Stan | May 01, 2014
On March 21, the Advisory Council on TCM (AC-TCM) met with Minister Rona Ambrose, Parliamentary Secretary Colin Carrie, Director General of the NHPD Adam Gibson and other Health Canada staff to further discuss issues relating to the regulatory process of Natural Health Products (NHPs) in Canada.   In December 2011, the then Health Minister Leona Aglukkaq established a special committee of TCM stakeholders to provide direct input to Health Canada. I had the privilege of being invited to be on this committee, and thus I am able to provide input as both a practitioner of TCM and an importer of TCM products into Canada.   This was our third meeting as a group and our first time to meet the current Health Minister Rona Ambrose. In the early days as a member of this committee, I often wondered about the sincerity and commitment of the Government to listen to the concerns of TCM practitioners in the new regulatory environment of the Natural Health Product Directorate (NHPD).   My concern was especially elevated as I witnessed TCM-prepared product after product being rejected for licensing. It felt to me, and many other stakeholders in the industry, that we were being shut down by an over-controlling bureaucracy. That was three years ago, and I am pleased to say that since the inception of the AC-TCM a respectful and responsive working relationship has evolved that has resulted in most of our TCM botanical medicines being licensed.   On our end, we have had to demonstrate that we as an importer have an ongoing monitoring process that checks the Certificate of Analysis (COA) for each lot of botanical products against the requirements set out by Health Canada. These include heavy metals, pesticides, yeasts, molds and fungi minimums. In addition to the COA screening and approval, we also perform our own third-party analysis of the imported products here in Canada to validate the safety of the botanicals. As a result of all these procedural additions, you can be sure that the medicines you prescribe to your patients have been doubly vetted for quality of herbs and contaminants.   On Health Canada’s end, the regulatory team established a TCM monograph database that we can reference in our product submissions. The database categorizes TCM botanicals into three categories based on degrees of risk. Using these monographs, manufacturers are able to combine ingredients based on TCM principles from these categories. As a result, all of our “novel” TCM patents have now been approved and your favorite products are now available. Products like Margarita Complexion Formula andChildren’s Ear Formula are back in stock!   At this third meeting of the AC-TCM, I was very much impressed with the HC’s sincere interest in TCM and its potential for integration into mainstream healthcare. Both Minister Ambrose and Parliamentary Secretary Colin Carey expressed deep respect for TCM, and both look forward to future meetings and input from the TCM community at future meetings.   I feel we have a very special opportunity here to offer some high-level input into the Health Ministry. If you have any ideas or concerns that you would like me to bring forward at these meetings, please feel free to contact me and I will be happy to bring your thoughts and ideas to our next meeting. Our healthcare landscape is changing because the government has recognized that good things are happening because of practitioners like you. So keep up the great grassroots work, those from above are indeed noticing. As I have often said, we are changing the world, one happy patient at a time!   John Stan, DrTCM Eastern Currents President and Founder   jstan@easterncurrents.ca     P.S. Please see this brochure for more information about the regulatory schedule for NHPs in Canada. The most important item here is that by August 31, 2014 all products on shelves should have an NHP number and the label should be compliant with the NHP number in place. Health Canada will start enforcing these label requirements. By September 1, 2014 all NHPs should have labels that will clearly list dosage, usage and cautions and contraindications.

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