The New Drugs List is an administrative list posted on the Health Canada website that represents substances or formulations in prescription and non-prescription drug products that have received approval (Notice of Compliance, NOC). Companies will use this list at times to determine if their products contain ingredients that may be defined as “New Drugs.” The New Drugs List posted on the Health Canada website has not been updated since 1999. If you weren’t aware before, you certainly are now…
Health Canada has finally confirmed that they won’t be updating the list at all moving forward, citing: “With the increasing workload and limited resources in TPD, updating and the annual maintenance of a list which is not all encompassing or up-to-date at any given time were not considered an efficient use of resources.” This doesn’t mean the end of the world. Currently, there is public access to other sources on the Health Canada website to assist industry in making drug status assessments for products such as subsequent market entry drug products (i.e. generics) and to analyze what ingredients may be considered as new drugs.
When in doubt, there are the Canadian Food and Drug Regulations, specifically Part C, Division 8 which provides the definition of a “New Drug.” This is a valuable source for determining if a product falls under the New Drug category, but may require the help of a regulatory professional to interpret the definition correctly.
For information on any new drugs approved to date, the NOC Listings and database can be utilized on the Health Canada website. This can help determine whether a Canadian product was granted market authorization through the issuance of an NOC and help determine if an ingredient is a part of a new drug; however, this method won’t tell you if the drug is currently on the Canadian market. There are other strategies too!
What to Do:
- If you need help identifying new drugs, so feel free to ask FPR for assistance in identifying New Drugs.
If you have any questions about how to classify products such as: Drugs, NHPs, Medical Devices, Pesticides, Consumer Products and Cosmetics, just ask FPR