Canada Gazette Part I from Décembre 20th contains a posting in Volume 159, No. 51: Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs.
In summary, it appears the Order allows the Minister to rely on decisions or documents from certain foreign regulatory authorities (FRAs) instead of fully examining specified information in a new drug submission.
To ensure safety and minimize risk, the Order requires that:
- The drug belongs to a class listed on an incorporated-by-reference (IbR) list.
- The manufacturer proves the drug is authorized by an FRA on that list for the same class.
- Any differences between the submitted drug and the FRA-approved drug do not negatively affect safety or effectiveness.
The Minister will review information on those differences and other Canada-specific aspects (e.g., labeling). If differences could impact safety or effectiveness, the Minister will conduct a full review for that part of the submission instead of relying on FRA decisions.
As promised in our previous notice, CA has reviewed the announcement. This does not appear to address a faster route to market for low-risk health product as:
- the need to file a new drug submission has not been eliminated and
- does not address ingredients, only products.
