Health Canada recently announced their initiative to modernize the regulatory framework for health products and foods. This is required due to a variety of factors, such as new and emerging science breakthroughs and public health threats worldwide. The modernization is also based on public input regarding the need for greater transparency. The Canadian federal government published a Red Tape Reduction program in January 2012, and some of the reasons for change also stem from this report.
The NHPD recently released a Standards of Evidence document that is currently under consultation review by stakeholders. This consultation review is set to end August 21, 2012. The document takes a risk based approach to health claims and may allow lower risk claims to be made based on non-human studies (e.g. In vitro animal studies) as long as safety data in humans is available. Essentially this review and licensing will be based on three class levels, each having a level of risk. In addition to this license evaluation approach there are new timelines proposed. The chart below illustrated the current and future timelines:
|Class||Current Timeframe||Future timeframe|
|1 – High level of certainty|
– (eg. Monographs, AbLs, Category IV/TPD labeling
|60 days||10 days|
|2 – Medium level of certainty – a combination of pre-cleared information and high quality data from peer reviewed published journals||180 days||30 days|
|3 – Low level of certainty – clinical trial evidence and full pre-market assessment||180 days||180 days|
Based on the amount of information that the NHPD has gathered over the last 8 years and pre-cleared information through NHPD monographs, the anticipation is that 99% of all product license applications would be reviewed in 30 days or less. With the Exemption number program set to expire in February, the NHPD is under the gun to clear the backlog and introduce a new process. After UPLAR expires in February, the mandate will be in place so that products will not be allowed for sale unless an NPN is issued.
These new target review timelines are a major requirement forcing companies to set dates for products on shelf with their retail partners. The new framework will hopefully prevent any future backlogs. Based on the rapid response that Quality Smart Solutions has seen in the past year, from license submission to license issuance for our clients, it is encouraging that the NHPD will meet their target of clearing the backlog and repeal UPLAR without further extension of the regulations past the due date. We also anticipate many more monographs to be published between now and next February. Quality Smart Solutions will keep you updated as this new approach develops and becomes reality.
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Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.
Contact us today to learn more about how we can support your compliance needs during and after licensing!