For those IPPractice subscribers monitoring through the new listings on Health Canada’s Register of Innovative Drugs, the Health Canada was changed recently so today’s email includes missed updates from the last while. If you are not, but are interested in innovative drug updates, you can add this feature through your subscription preferences.
Health Canada’s Register of Innovative Drugs are drugs identified under C.08.004.1(9) of the Food and Drug Regulations to which data protection applies.
The monitoring through IPPractice provides a listing of drugs newly added to the register, the date the NOC was granted and the date when data protection expires.
The regulations provide that:
(3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug,
(a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and
(b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.