The pathway to market governing the assessment of novel food authorizations in the United Kingdom has recently changed and this could affect your regulatory responsibilities. Prior to Brexit, the European […] Read More >>
Health Canada’s new NHP GMP Inspection Pilot Program is here and depending on the outcome, it could be here to stay. If made permanent, this program will mark the beginning […] Read More >>
Changes are coming to food importers of meat, fish, dairy, eggs, processed eggs, processed fruits and vegetables, honey, maple, fresh fruits and vegetables, and other unstandardized food products. Starting March 15, 2021, […] Read More >>
Dietary supplement marketers selling on Amazon are now being asked to provide testing results and other manufacturing information on their supplement products in order to remain on Amazon’s site for […] Read More >>
To quote Henry David Thoreau, “it is not enough to be busy; so are the ants. The question is: What are we busy about.” The Safe Food Quality Institute (SQFI) […] Read More >>
In May of 2019, Health Canada announced a “Notice of Consultation on the Prescription Drug List: Vitamin D”. This notice opened up to public consultation the proposal to amend the Prescription […] Read More >>
If you are involved in the importation or distribution of Medical Devices related to the COVID crises in Canada, then no doubt you are aware of Health Canada’s online database […] Read More >>
Clinical trials proceed with four phases to assess the safety and efficacy of an Investigational Product (IP) [1]. The sample size should be considered with extra care for each of […] Read More >>
The Canadian Food Inspection Agency (CFIA) announced on October 30, 2020, that it would update its Compliance and Enforcement Policy, which would come into effect on November 1, 2020. The […] Read More >>
The dates for renewal are now open. The Food and Drug Administration (FDA) requires that all businesses that manufacture, process, pack, or store food, beverages, or dietary supplements for sale […] Read More >>
Labelling of packaged food in Canada has undergone some regulatory changes in the last few years, and there are some proposals for label revisions that have been active for some […] Read More >>
In Canada, prior to July 1, 2020, drugs, which are inclusive of prescription drugs, non-prescription drugs (also called over-the-counter [OTC] pharmaceuticals), and natural health products (NHPs), were not permitted to […] Read More >>
Recruitment is a crucial part of the Clinical Study workload. Even if no clinical trial is actively searching for subjects, recruitment is an ongoing process in order to build a […] Read More >>
Put yourself in the shoes of the consumer for a minute…okay…ready? You walk into a health food store to purchase supplements that you recently learned about that you hope might […] Read More >>
The temporary exemptions for the importation of hand sanitizers, which was announced March 27, 2020, as part of the Natural and Non-Prescription Health Products Directory (NNHPD)’s interim measures have now […] Read More >>
In the US, drugs may either be prescription drugs, requiring a prescription by an authorized health care provider, or they may be over-the-counter (OTC) drugs, which are purchased directly by […] Read More >>
A “Brand Name” is defined as the name under which your NHP (Natural Health Product) is registered or sold. Selecting a “Brand Name” for your NHP is an important part […] Read More >>
On July 15, 2020, the next scheduled compliance date for the Safe Food for Canadians Act & Regulations came into effect for businesses in the manufactured food sector. The compliance […] Read More >>
In addition to governing pharmaceutical and medical device research, Health Canada provides oversight and approval of nutraceutical clinical research and natural health products conducted in Canada. This integrated approach allows […] Read More >>
In response to the COVID-19 pandemic, Health Canada implemented in March and April 2020 interim measures aimed to facilitate the importation of products that can help to limit the spread […] Read More >>
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