1. Health Canada/FDA Favorite Links Lynda Paleshnuik Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009

2. Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 2 |2 | Health Canada Favorites 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

3. Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 3 |3 | Health Canada Favorites 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

4. Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 4 |4 | Health Canada Favorites Included in Quality Guidance Documents: Drug Master Files Pharmaceutical Sciences – Questions and Answers Impurity Guidances Inhalation and Nasal Products Aqueous Solutions

5. Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 5 |5 | Health Canada Favorites General Quality Guidance for New and Generic Applications Stability Testing Stereochemical Issues

6. Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 6 |6 | Health Canada Favorites 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

7. Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 7 |7 | Health Canada Favorites Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-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

8. Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 8 |8 | Health Canada Favorites 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.”

9. Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 9 |9 | FDA Favorites FDA Guidance Documents (searchable): http://www.fda.gov/Drugs/GuidanceComplianceRegulator yInformation/Guidances/default.htm All Chemistry Guidances: http://www.fda.gov/Drugs/GuidanceComplianceRegulator yInformation/Guidances/ucm064979.htm

10. Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 10 | FDA Favorites 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

11. Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 11 | FDA Favorites Searchable dissolution method database: http://www.accessdata.fda.gov/scripts/cder/dissolution/