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Wednesday, February 22, 2012

Health Canada - Acts, Regulations and GCP

ACTS:

Food and Drugs Act:

http://laws.justice.gc.ca/en/F-27/index.html

Controlled Drugs and Substances Act:

http://laws.justice.gc.ca/en/C-38.8/index.html

REGULATIONS:

Food and Drugs Regulations:

http://laws.justice.gc.ca/en/F-27/C.R.C.-c.870/index.html

Medical Devices Regulations:

http://laws.justice.gc.ca/en/F-27/SOR-98-282/index.html

GOOD CLINICAL PRACTICES:

Classification of observations made in the conduct of inspections of clinical trials:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/docs/gui_0043_tc-tm-eng.php

Inspection strategy for clinical trials:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/docs/insp_strat_tc-tm-eng.php

Summary report of clinical trial inspections (2003 & 2004):

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/report-rapport/2003-2004_tc-tm-eng.php

Guidance for records related to clinical trials:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/docs/gui_68_tc-tm-eng.php

Guidance for industry: GCP - Consolidated Guideline:

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/e6-eng.pdf

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