Learn about the FDA’s delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations.
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Understand Health Canada’s 2025 fees for NHPs, drugs, medical devices, and cannabis. Stay compliant with Quality Smart Solutions.
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If you’re in the business of nicotine replacement therapies, major regulatory changes are now in place.
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Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input The Natural and Non-Prescription Health Products Directorate (NNHPD)
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FDA User Fees for Fiscal Year 2025 (FY2025) The FDA’s user fees for FY2025, which runs from October 1, 2024,
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GRAS Experts, a new division aimed at tackling ingredient safety concerns and helping businesses stay ahead of regulatory changes and
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The NNHPD Opens Consultation on Batch 4 Through new guidelines, stakeholders are invited to shape the future of homeopathic and
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The FDA has taken a significant step forward in its ongoing sodium reduction initiative by issuing new, voluntary sodium reduction
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Health Canada Approves Alpha GPC in Foods On September 20, 2023, Health Canada approved the use of L-alpha-glycerylphosphorylcholine (alpha GPC)
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https://youtu.be/uuXA8yHrrZc Introduction: In response to the FDA’s recent draft guidance on the Registration and Listing of Cosmetic Product Facilities and Products,
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Introduction: Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023,
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Introduction In a groundbreaking move, the Association of American Feed Control Officials (AAFCO) has given the green light to an extensive overhaul
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The Canadian Food Inspection Agency (CFIA) has regulated food products for many years, with a particular focus on the safety
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https://youtu.be/uuXA8yHrrZc Introduction: Behold the “Modernization of Cosmetic Regulation Act of 2022” that President Biden signed on December 29, 2022. This
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This guidance provides suggestions and instructions to assist in submitting cosmetic product facility registrations and product listings to the FDA.
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Introduction: Health Canada’s new dietary supplement regulations, which are intended to revamp an already successful system, are unintentionally harming both
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The safety evaluation of direct food additives and color additives used in food will be evaluated in this blog post
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The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition
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Introduction: By extending the interim policy on the importation and sale of infant formulas, human milk fortifiers, and dietary products
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What improvements are being made to support NHP site licensing? Internal template updates support: consistency between reviews-Fall 2023 Increased efficiencies
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Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product
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Introduction: In a recent update released on March 27, 2023, the FDA announced it has stopped accepting and processing VCRP submissions to
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As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
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The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023
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PMRA Annual Fees reduced for Reporting and Applications: Health Canada is implementing a new approach beginning April 1, 2023.
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Background: Health Canada issued three interim orders to allow the importation and sale of medical devices used to diagnose,
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Introduction: The sections relating to the disclosure of fragrance allergens because of the regulations go into effect two years following
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Introduction: The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of
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Introduction: Submitting a new drug to Health Canada can be a complex and time-consuming process. This post will provide
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Introduction: The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling
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Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients.
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Introduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning
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Introduction: FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand
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The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and
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U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation
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Health Canada Announcement: The Minister of Health has introduced new front-of-package nutrition labeling laws for prepackaged food products, and
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The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
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Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
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https://youtu.be/veCBMkYUWEU Market Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG)
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Navigating the FDA and NAC regulations can be intimidating, but with the right information and guidance, you’ll be able to
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Have you been anticipating the Food and Drug Regulations (FDR) adding supplemented foods as an official category of food?
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What are the latest Natural Health Product Amendments (NHPR) Health Canada will be amending the Natural Health Products Regulations (NHPR)
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Health Canada recently announced that Front-of-package labelling changes for foods are set to come into effect on July 20, 2022,
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Background On April 22, 2022, Health Canada issued a notice to the industry on the interim implementation of electronic
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COVID had significantly impacted the processing of NHP product license applications with delays in the processing of all classes of
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In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
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On January 19, 2022, Health Canada announced a marketing authorization (MA) to permit manufacturers to voluntarily increase the amount of
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On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices
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Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim
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What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
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Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification
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The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or
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Summary of Health Canada Licensing and Update Reports Product Licensing A combined 1390/5045 (28%) of NHP product license application submissions
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On November 24, 2021, The Food and Drug Administration (FDA) sent correspondence to industry requesting information on the past use
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On October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides
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In the wake of the COVID-19 pandemic, preventive measures and a healthy lifestyle with an efficient immune system were suggested
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It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
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The “Sunshine” vitamin, Vitamin D, Vitamin D3 or Vitamin D2 as it is more commonly known. The term “sunshine” was
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What is a Cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
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On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
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Health Canada and the CFIA (Canadian Food Inspection Agency) are teaming up to plan advancements and improvements for the timing
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In March 2020, Health Canada introduced interim measures to expedite the issuance of site licences for alcohol-based hand sanitizers, to
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On June 26, 2021, Health Canada launched a consultation on a proposal to improve natural health product labelling. Health Canada
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On June 25, 2021, Health Canada published a news release that announced proposed changes to the Natural Health Products Regulations.
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On June 12, 2021, the Canadian Food Inspection Agency (CFIA) opened a consultation as part of the process to modernize
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Health Canada has been working on creating/revising the regulations with regards to Supplemented Foods for some time now. A recent
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Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,
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Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements On May 27, 2021 Health Canada
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CFIA and Health Canada have been working on new Food Safety guidance documents pertaining to Novel foods focused on plant
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As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of
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Sesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The
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The coronavirus-19 (COVID-19) pandemic has had a long-lasting effect on many of the processes done in business and everyday life.
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After consultation with stakeholders and based on a noticeable lack of current regulations and need for availability and innovation for
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Health Canada and the Canadian Food Inspection Agency have joined forces to evaluate the incorporation of Veterinary Health Products (VHPs)
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In order for food that is regulated under the Safe Food for Canadians Regulations, to be imported into Canada, the
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On October 5, 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) sent a notice to all Canadian product licence
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On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability record
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On May 23, 2020, the Minister of Health of Canada approved an Interim Order (IO) Respecting Clinical Trials for Medical
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Recently in Canada, the Minister of Health has signed an Interim Order to allow expedited access to COVID-19-related medical devices
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In September Amazon.ca notified every Natural Health Product vendor (whether they had an NPN or not) that, effective in October
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On November 14, 2017 the Natural and Non-prescription Health Products Directorate (NNHPD) announced that there are several updates to the
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This past June 2017 the Food and Drug Administration (FDA) put a hold on the compliance dates for Nutrition Facts
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As discussed in an earlier post (PLL – Plain Language Labeling: What it means and how it affects you), the
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Our sister company, Quality IMPORT Solutions has a new website with all the information you need to make an informed
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Significant changes are occurring in the global regulatory landscape as of late, and this is just another example of how
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We hope you found it as successful as we did. Feel free to email us at info@qualitysmartsolutions.com or give us
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