比較広告
カナダ ／ Health Canada／PAAB
治療上の比較表示は、比較する薬剤に共通の承認適応があり、同一の使用条件での比較であり、各製品の承認内容と矛盾せず、臨床的に意味があり、確定的な証拠に基づき、比較対象を明示しなければならない。
A therapeutic comparative claim must involve drugs sharing an authorized indication, compare them under the same conditions of use, not conflict with the compared products' terms of market authorization, be clinically relevant, rest on conclusive evidence, and identify the compared entities.
注記
The directive states section 9(1) of the Food and Drugs Act as its legal basis. The same policy text is reproduced verbatim as sections 5.1-5.6 of the PAAB Code, which adds (5.7) that comparative efficacy and safety claims generally require head-to-head randomized evidence and (5.7.1) that data from two separate product monographs or non-head-to-head studies are not acceptable support.
The directive states section 9(1) of the Food and Drugs Act as its legal basis. The same policy text is reproduced verbatim as sections 5.1-5.6 of the PAAB Code, which adds (5.7) that comparative efficacy and safety claims generally require head-to-head randomized evidence and (5.7.1) that data from two separate product monographs or non-head-to-head studies are not acceptable support.