Health Products and Food Branch

Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch, Health Canada, Ottawa, Ontario, Canada... 

Compendium of Methods for Chemical Analysis of Foods, Bureau of Chemical Safety, Health Products and Food Branch, Health Canada, Ottawa, Ont., Canada, Method LPFC-137 (1985). (http //www.hc-sc.gc.ca/fn-an/res-rech/analy-meth/chem/reg prep dry ashing-reg prep echantillons calcination e.html). 

Health Canada. Good Manufacturing Practices Guidelines. 2002 ed. Health Products and Food Branch Inspectorate (Dec. 2001). 

Canada Health Products and Food Branch (HPFB)... 

New therapeutic products can be sold in Canada once they have successfully passed a review process to assess their safety, efficacy, and quality. Responsibility for this review process rests with Health Canada s Health Products and Food Branch (HPFB). 

A procedure should be developed describing how to handle requests by regulators for documentation. Where requested, access to master (or copies of) documents (including raw data such as test evidence) should be provided within reasonable time frames, normally 24 to 48 h depending on circumstances. The Canadian Health Products and Food Branch Inspectorate, for instance, requires records to be accessible within 48 h. The FDA has similar requirements for off-site paper-based archives. Service Level Agreements between central support functions and sites should define the service levels for access to documentation. 

The National Health Products Directorate and Health Products and Food Branch of Health Canada believe these new policies, when fully enacted, will serve the consumer well. By meeting quality and safety standards based on good manufacturing practices and only allowing health claims supported by appropriate levels of evidence to accompany natural health products, the basis for rational use has been established (Health Canada, 2004). 

In January 2004, The Market Health Products Directorate (MHPD) of the Health Products and Food Branch (HPFB) posted some information in regards to this situation. Janssen-Ortho Inc., consulted with Health Canada and revised their prescribing information. They mentioned that Eprex was supplied in two formulations with different stabilizers, one containing polysorbate-80 and the other containing human serum albumin (HSA). It also cautioned that subcutaneous administration of recombinant human proteins may in-... 

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