September 27, 2010
by Stephanie Martyres
The Canadian Natural Health Products (NHP) industry recently faced a number of changes with the implementation of the Unprocessed Production License Application Regulations (UPLARs), and new policies surrounding processing of product license applications (PLAs), regulatory compliance and enforcement. These new measures are intended to address issues that have arisen since the introduction of the NHP Regulations.
A six-year transition period to bring all NHPs, also known as dietary supplements, into regulatory compliance began in 2004 with the implementation of the NHP Regulations. Throughout this period, both industry and the NHP Directorate (NHPD) have faced numerous challenges, the biggest of which was dealing with the large number of PLAs submitted to the NHPD, resulting in many applications sitting in the submission queue for years without assessment. During this period, numerous unlicensed products were still being sold on the market as long as they had a PLA submission number; however, as the transition period drew to a close in late 2009, many wondered how the NHPD would address the issues surrounding the sale of unlicensed products.
To complicate matters, in January 2010, the National Association of Pharmacy Regulatory Authorities (NAPRA) issued a position statement that pharmacies should not sell any marketed health products that did not have premarket approval, as they may pose a risk to public safety, putting in jeopardy a host of NHPs that were already on the Canadian market. In response, Health Canada has introduced the UPLARs, a new Application Management Policy, and a new Compliance and Enforcement Policy, finally answering one of the industrys biggest questions: What happens next?
Promulgated on Aug. 4, 2010, the UPLARs provide a temporary measure to enable the legal sale of unlicensed products. Under the UPLARs, products for which PLAs have been in the submission queue for at least 180 days, barring certain exclusion criteria, are eligible for an exemption number as proof of their legal status until a licensing decision has been made by the NHPD. With the requirements that information, such as brand name, company name and other product details, be made publicly available, and that the exemption number must appear on the product label, applicants must either opt-in to the exemption-number system or commit to not sell their product until a product license has been granted. The UPLARs remain in force for a period of 30 months.
For new applications, the UPLARs, together with the NHPDs new Application Management Policy, have introduced a new 180-day waiting period following the receipt of a submission acknowledgement notice before products can be marketed. However, this waiting period also must take into account a 30-day timeframe to obtain a submission number. Under the new Policy, PLAs will no longer automatically receive a submission number; instead, a preliminary review of the PLA will be conducted up front to determine whether evidence supporting the safety and efficacy of the product has been submitted. Following the initial review, the NHPD will either issue a submission number or refuse the application. The new Application Management Policy is the NHPDs latest effort to streamline the application review process and work toward a performance standard to complete the review of PLAs that require a full assessment of safety, efficacy and quality within 180 days.
Applicants also will need to plan the timing of their PLA submission accordingly, as the NHPD will require all ingredients in a product be listed in the NHP Ingredients Database, whether medicinal or non-medicinal. Previously, the NHPD completed this task; however, under the new Application Management Policy, it is up to applicants to request new ingredients be added to the database, a process that takes approximately four weeks to complete. It is important to note, however, that apart from non-medicinal ingredients, the presence of a medicinal ingredient in the database does not constitute approval for its use in NHPs.
Finally, the piece of the pie that everyone has been waiting for: Health Canadas new Compliance and Enforcement Policy for NHPs, which took effect Aug. 27, 2010. As per the previous policy, compliance and enforcement continues to be based on risk to human health. The first six months (August 2010 to February 2011) will be a promotions period intended to provide stakeholders with information about how to be compliant with the regulations, with the primary focus on those products sold on the market for which a PLA has not yet been submitted. Following this period, full implementation of the policy will occur.
The new regulations and policies will have a tremendous impact on the NHP industry in Canada. With the UPLARs, Health Canada has found a way to temporarily address the issues surrounding the sale of non-compliant products in the Canadian market that await their product licenses. However, new products will be eligible to enter the market 180 days following receipt of their application submission number, which, together with the 30-day period to receive the submission number, results in a waiting period totaling 210 days. While the NHPD is aiming for a 180-day performance standard for the review of PLAs that require full assessment, the agency has not actually demonstrated it can meet this target, and it is unclear as to when applications that are still in the queue will be completed. Thus, the 30-month timeline for the UPLARs may go by very quickly.
For those intending to market new products in Canada, the timing of PLA submissions and plans for market entry are critical, as is ensuring PLAs are complete and of high quality. It is important, as much as is possible, to get it right the first time to avoid delays in pursuit of that all-important product license.
Stephanie Martyres is a scientific and regulatory consultant with Cantox Health Sciences International. For more information on how the new regulations and policies may affect you, visit Cantox at SupplySide West 2010, Booth #16085, or contact Martyres at smarty [email protected] .
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