Health Canada/FDA Favorite Links Lynda Paleshnuik Training workshop: Assessment of Interchangeable...

Health Canada/FDA

Favorite LinksLynda Paleshnuik

Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009

Assessment of Interchangeable Multisource Medicines, Kenya, August 20092 |

Health Canada FavoritesHealth 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



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



Included in Quality Guidance Documents:

Drug Master Files

Pharmaceutical Sciences – Questions and Answers

Impurity Guidances

Inhalation and Nasal Products

Aqueous Solutions



General Quality Guidance for New and Generic Applications

Stability Testing

Stereochemical Issues



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



Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format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



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.”


FDA FavoritesFDA Favorites

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



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



Searchable dissolution method database:

http://www.accessdata.fda.gov/scripts/cder/dissolution/

Health Canada/FDA Favorite Links Lynda Paleshnuik Training workshop: Assessment of Interchangeable...

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