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Health committee  Yes, I will add caution by saying that we are seeing that many more of the applications that come to Health Canada are for orphan indications. Relating to the question on genetic testing, as Dr. Stewart said, we're seeing a lot of medications coming through where as a result of

September 27th, 2018Committee meeting

Catherine Parker

September 27th, 2018Committee meeting

Catherine Parker

Health committee  We have already launched a number of achievable items in the regulatory review of drugs and devices. We are planning to have the entire initiative completed by the end of 2021. However, we have already launched a number of things. We now offer aligned reviews between the regula

September 27th, 2018Committee meeting

Catherine Parker

Health committee  Karen Reynolds will answer that question.

September 27th, 2018Committee meeting

Catherine Parker

Health committee  I will refer that to Dr. Stewart to answer.

September 27th, 2018Committee meeting

Catherine Parker

Health committee  That's a very difficult question to answer.

September 27th, 2018Committee meeting

Catherine Parker

Health committee  I will comment and then pass it to Dr. Stewart. We acknowledge that clinical trials have restrictions and may not reflect what happens once a drug goes into what we call real-world use. That is one of the reasons we have a conditional approval system for some of these products,

September 27th, 2018Committee meeting

Catherine Parker

Health committee  As the regulator, certainly, our priority is to make sure that as orphan drugs are being developed they come to Canada. We want to see sites in Canada for clinical trials so that patients can have access through that, and so practitioners can become familiar with the products. Al

September 27th, 2018Committee meeting

Catherine Parker

Health committee  I will ask Dr. Stewart to answer that question.

September 27th, 2018Committee meeting

Catherine Parker

Health committee  Yes, we certainly do. We're very much involved in collaboration with our international regulatory partners. At the time of a request for authorization, we consider whether a product has been approved in another jurisdiction, particularly with our partners in the United States Foo

September 27th, 2018Committee meeting

Catherine Parker

Health committee  Good morning. Thank you for the opportunity to be here today to discuss Health Canada's role in maximizing the quality, safety and effectiveness of drugs for rare diseases and in making these drugs available to Canadians. Joining me today is Dr. John Patrick Stewart, and Ms. Ka

September 27th, 2018Committee meeting

Catherine Parker

Health committee  No, but it's equally rigid. There are various aspects of the plasma donation process designed to try to eliminate people who may be there just to collect the small payment. They need to provide proof of a fixed address and things like that. The donor screening and the donor testi

December 8th, 2016Committee meeting

Catherine Parker

Health committee  Yes, I hope so. I'd like to clarify that plasma donors in Canada are very strictly regulated. Plasma donation is strictly regulated. Plasma donors, whether they are paid or not, go through a very rigid screening process.

December 8th, 2016Committee meeting

Catherine Parker

Health committee  It's a different situation, because the plasma is processed, and it's actually processed into commercial drugs. There is that whole processing step.

December 8th, 2016Committee meeting

Catherine Parker

Health committee  In addition to regulating the blood supply, we are also responsible for the regulation of pharmaceutical and biologic drugs. I can confirm that there has been a great deal of development in the drug field in products that can be used as alternatives to blood, not just in developi

December 8th, 2016Committee meeting

Catherine Parker