Post on 18-Dec-2015
Health Canada/FDA
Favorite LinksLynda Paleshnuik
Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009
Assessment of Interchangeable Multisource Medicines, Kenya, August 20092 |
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Main Agency Site: “Drugs and Health Products”
http://www.hc-sc.gc.ca/dhp-mps/index-eng.php
Drug Products:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/index-eng.php
Assessment of Interchangeable Multisource Medicines, Kenya, August 20093 |
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Drug Product Guidance documents:
General:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/index-eng.php
Chemical Entity Products/Quality
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/chem/index-eng.php
Assessment of Interchangeable Multisource Medicines, Kenya, August 20094 |
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Included in Quality Guidance Documents:
Drug Master Files
Pharmaceutical Sciences – Questions and Answers
Impurity Guidances
Inhalation and Nasal Products
Aqueous Solutions
Assessment of Interchangeable Multisource Medicines, Kenya, August 20095 |
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General Quality Guidance for New and Generic Applications
Stability Testing
Stereochemical Issues
Assessment of Interchangeable Multisource Medicines, Kenya, August 20096 |
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Pharmaceutical Sciences – Questions and Answers
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/chem/ps_qa_sp_qr-eng.php
Pharmaceutical Quality of Aqueous Solutions
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/chem/aqueous_aqueuses-eng.php
Assessment of Interchangeable Multisource Medicines, Kenya, August 20097 |
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Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ctdnds_ctdpdn-eng.php
Summary basis of decision (SBD)
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/index-eng.php
Assessment of Interchangeable Multisource Medicines, Kenya, August 20098 |
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DIN guidelines for quality information
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/chem/dinas_ddin-eng.php
“Regardless of the information provided by the supplier of the drug substance, the manufacturer of the dosage form is responsible for ensuring that acceptable specifications and properly validated analytical procedures for the drug substance are developed by the manufacturer’s facilities and for providing the results of batch analyses performed at the manufacturer's facilities.”
Assessment of Interchangeable Multisource Medicines, Kenya, August 20099 |
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FDA Guidance Documents (searchable):
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
All Chemistry Guidances:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064979.htm
Assessment of Interchangeable Multisource Medicines, Kenya, August 200910 |
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Searchable Drug Database:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Inactive Ingredients List (Searchable):
http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
Assessment of Interchangeable Multisource Medicines, Kenya, August 200911 |
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Searchable dissolution method database:
http://www.accessdata.fda.gov/scripts/cder/dissolution/