Issue link: http://clhia.uberflip.com/i/406567
6 a.2 Approval of New Drugs Health Canada reviews every new drug product before it can be sold in Canada. The process can take between one to two years and includes three main steps as set out below. 1. The drug manufacturer must submit scientific proof to Health Canada that the product: − is safe; − does what it is supposed to do; and − follows all Canadian quality standards. 2. Health Canada reviews and approves the drug if it meets these conditions. 3. Health Canada issues a Notice of Compliance (NOC) and a Drug Identification Number (DIN) for all new approved drug products. Overall, Health Canada strives to maintain a balance between the potential health benefits and risks posed by prescription drugs, with the highest priority being public safety. a.2.1 Improving Speed to Market of New Drugs The approval process for prescription drugs in Canada generally works well. Health Canada currently prioritizes the review of breakthrough drugs through its Priority Review of Drug Submission Policy. However, there may be scope to increase the pace with which new drugs get approved. For example, in 2010, Health Canada took 527 days, on average, to approve new drugs, up from 472 days in 2009. Moreover, between 2006 and 2010, Health Canada took longer to approve new drugs than regulators in Europe and longer than the U.S. FDA in six of the seven years spanning the period between 2004 and 2010. 4 A thorough approval process is important to ensure that the health outcomes of new prescription drugs are well understood and that patient safety is protected. However, the 4 Mark Rovere and Brett J. Skinner. Access Delayed, Access Denied 2012: Waiting for New Medicines in Canada. Fraser Institute.