Canadian guidelines for generics

Home/Guidelines | Posted 20/10/2010 post-comment0 Post your comment

Last update: 3 August 2012 

The regulatory body for approval of medicines in Canada is the Therapeutic Products Directorate of Health Canada.

Health Canada develops and enforces regulations under Canadian governmental legislation.


Health Canada applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality.

The Canadian Food & Drugs Act and Regulations were amended in 1995 in order to allow for a generics manufacturer to file an Abbreviated New Drug Submission (ANDS). This allows:

  • Establishment of bioequivalence by requiring a Canadian Reference Product (CRP)
  • Same route of administration as CRP
  • Same conditions of use as the CRP
  • Ensured safety, efficacy and high quality

An ANDS typically requires bioequivalence, chemistry & manufacturing and/or pharmaceutical equivalence data to be submitted, but does not require preclinical data, which is normally required for an originator drug.

Canada has the following guidelines for generic medicines:

1.  Overarching Guideline
This guideline covers all generic products:

Notice - Integrated Review of Abbreviated New Drug Submissions (ANDSs)
Date: 1 October 2007

2. General Guidelines
These guidelines cover all generic products:

Quality Overall Summary – Chemical Entities (New Drug Submissions/Abbreviated New Drug Submissions) (QOS-CE [NDS/ANDS])
Date: 1 April 2004

Draft Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Date: 18 July 2001

Related article

Canadian guidelines for biosimilars

Source: Health Canada

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010