Canadian guidelines for generics

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Canadian guidelines for generics

INICIO/Directrices | Posted 20/10/2010 0 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
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/notice_ands_rev_avis_padn_pro-eng.pdf

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
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/qoscendsands_sgqecpdnpadn-eng.pdf

Draft Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Date: 18 July 2001
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/qual_ndsands_pdnpadn_07-01-eng.pdf

Related article

Canadian guidelines for biosimilars

Source: Health Canada