Canadian guidance covers use of foreign data in drug reviews

01/22/2013 | Financial Post (Canada)

Health Canada unveiled a draft guidance regarding the use of data from similar foreign regulatory agencies such as the European Medicines Agency and the FDA. "The Use of Foreign Reviews by Health Canada" covers abbreviated and supplemental new drug submissions, periodic safety update reports, medical device licenses, risk management plans, drug identification number applications and notifiable changes. The guidance aims to establish a framework for more consistent use of foreign reviews in Canada's approval of health products.

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Financial Post (Canada)

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