Globepharm Consulting ‚ÌGMPŠÖ˜A‹Æ–±‚Ì‚²ˆÄ“à


A Summary Report by the Canadian PHFBI@Fri. 29 Jan. 2010


Dear Colleagues:
Today the Canadian HPFBI issues a summary report covering "Post-Market Reporting Compliance Inspections (2005-2008)". The report is intended to assess compliance of manufacturers to the reporting of adverse drug reactions, and to the reporting of unusual failure in efficacy of new drugs. The report covers the findings of inspections of 309 Canadian facilities between 2005 and 2008.

The five main deficiencies noted were, in decreasing frequency:
. the reporting of domestic and foreign adverse drug reactions within 15
days to Health Canada,
. the maintenance of records related to adverse drug reactions,
. the preparation of annual summary reports,
. the maintenance of records related to unusual failure in efficacy of new drugs, and
. the reporting of domestic and foreign unusual failure in efficacy of new drug within 15 days to Health Canada.

The entire document (report) can be downloaded at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/gmp-bpf/docs/sum_rep_pmrc-rap_som_cedac_ltr-doc-eng.pdf

With Best Regards,

Michael Anisfeld
Globepharm







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