Canada – Regulatory Affairs
The Canadian pharma sector is one of the most innovative industries in Canada, and due to its strong industry footprint and positive clinical trial environment, many global pharma companies have been increasing their investments in the pharma sector over the past few years contributing to the steady growth of the industry.
Regulatory Body - Health Canada
Pharma Prescription Drugs
In Canada, prescription and OTC pharma products including disinfectants and sanitizers all fall under the label of “drug product” and have similar pathways to registration.
Consumer Healthcare Drugs/OTC
In Canada, Consumer Healthcare and OTC drugs fall under the same category as Rx products and are deemed as “drug products”. However, there are some exceptions for OTC drugs that allow for a fast-tracked registration product through the use of pre-established monographs.
With our long-term experience and network with Health Canada, we can offer a relatively fast registration process for Consumer Healthcare & OTC drugs in Canada.
Medical Devices
In Canada, Medical devices are controlled based on a classification system. There are four classes of Medical Devices (I, II, III, and IV) based on the degree of risk they present. The rules for device classifications are quite specific and can vary greatly depending on different criteria. Class I devices are subject to the least regulatory control and class IV, the most.
In addition to having different classes, different regulatory pathways also exist for bringing your medical device to the market. Class I devices do not require a license to be sold in Canada, Class II devices require a license application, Class III devices require a valid ISO 13485 certificate and Class IV devices must go through a lengthy process with Health Canada including extensive data on safety.
Food Supplements/Nutraceuticals
Food supplements and nutraceuticals in Canada are labelled as “natural health products” and are classified as OTC products. Therefore, natural health products are regulated as a subset of drugs under the Canadian Food and Drugs Act. The level of supporting documentation required by Health Canada depends on the health claims of the product in question, but in general, a Food Supplements/Nutraceuticals registration process in Canada is relatively fast and easy. However, there are specific regulations on limitations on the diet-related or nutritional content claims.
Cosmetics and Derma
In Canada, under the Food and Drugs Act, a cosmetic includes “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.”. Cosmetics products in Canada do not require premarket approval but a Cosmetics Notification Form detailing all the product ingredients must be submitted to Health Canada.
Photo by Rachael Annabelle on Unsplash
Frequently Asked Questions from clients – Regulatory Affairs
- FAQ - Prescription Products
- FAQ - OTC Products
- FAQ - Medical Devices
- FAQ - FS and Neutraceuticals
- FAQ - Cosmetics and Derma
- Will my existing BE studies be accepted in Canada?
- What are the important things to take understand with regards to
trademarks by Health Canada? - Can my home company act as a MAH in Canada?
- What is the difference in climate zone for stability studies in Canada vs. Europe and Asia?
- Is the fast track registration process possible for my products in Canada and what to be aware of?
- What are the pharma/prescription drug registration costs and time in Canada?
- How many trademarks should be suggested to Health Canada and why?
- How can my own company be MAH in Canada for my products?
- What are the Consumer Healthcare Drugs/OTC registration costs and time in Canada?
- How to register Herbal and Phyto OTC drugs in Canada via fast track process and why to prepare the market entry strategy before?
- What do I need to know about climate zone for stability studies in Canada?
- Is a fast track registration process available in Canada and what to make sure of?
- What is the difference between Medical Device registration and definition in Canada vs. Europe, Asia and throughout Latin America?
- Is my product considered a Medical Device by the laws of Health Canada?
- What are the important differences in trademark registration in Canada with regards to Health Canada for Medical Devices?
- Are local clinical trials necessary in Canada?
- Can my company act as a MAH in Canada?
- Climate zone for stability studies in Canada
- Is a fast track registration process available in Canada and what to be aware of?
- How difficult is the registration of Medical Devices in Canada?
- What are the Medical Devices registration costs and time in Canada?
- To which class of Medical Devices does my product belong?
- How to register claims on the pack for Food Supplements in Canada with Health Canada?
- Why trademark registration in Canada can be a very difficult task with Health Canada?
- Can my company act as a MAH in Canada for Food Supplements?
- What Climate zone for stability studies do I need for Food Supplements in Canada?
- How difficult is the registration of Food Supplements/Nutraceuticals in Canada?
- How to register claims in Canada for Cosmetics with Health Canada?
- Why is the trademark registration for Cosmetics and Derma products a big topic in Canada?
- Can my company act as a MAH in Canada or do I need a local partner for registration?
- What are the important topics about climate zone for stability studies in Canada?
- How difficult is the registration of Cosmetics in Canada?
- What are the Cosmetics registration costs and time in Canada?