Register of Innovative Drugs

The Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the Food and Drug Regulations. The register indicates the drugs that are eligible for data protection. Under C.08.004.1 (3) a subsequent manufacturer that seeks a notice of compliance on the basis of a direct or indirect comparison between the new drug and an innovative drug may not file a submission before the end of a period of six years after the day on which the first notice of compliance was issued for the innovative new drug. In addition, the notice of compliance cannot be issued before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator.

The format of the Register of Innovative Drugs is an electronic table, which is updated weekly. The register lists, in alphabetical order, the medicinal ingredients in the innovative drugs which were not previously approved in a drug by the Minister and that are not variations of a previously approved medicinal ingredient. Please note that there may be other medicinal ingredients included in the drugs. The register was re-formatted in summer 2016 to increase the clarity of the information provided regarding the medicinal ingredient, brand name and manufacturer of each innovative drug.

For information related to treatment options, choices of medications and their uses, illnesses, side effects or drug interactions, please contact your health care professional (for example, doctor, pharmacist, etc.). We do not provide medical advice regarding the use of the products identified in this database.

For comments or questions, please contact by opml_bmbl@hc-sc.gc.ca or by telephone at (613) 941-7281.

• Register of Innovative Drugs [2019-11-01]
• Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations [2010-03-08]