加拿大修订抗生素耐药性管理条例

 

    加拿大卫生部表示，抗生素耐药性已成为加拿大乃至全世界共同面临的问题。由于越来越多的致病菌对抗生素出现耐药性，抗生素对于疾病变得越来越没有效果。抗生素的滥用和误用是产生耐药性问题的重要因素。动物体内的耐药菌会对人体健康产生潜在威胁。本次条例的修订有助提升加拿大兽药类抗生素的监管水平。

 

    新条例主要涉及良好生产规范（GMP）要求、许可证（EL）要求、抗生素销售信息等内容。

 

    本条例第7条第8（1）及（3）及第9条在2018年5月17日实施，其余条例自2017年11月17日开始实施。

 

    部分原文报道如下：

 

    Regulations Amending the Food and Drug Regulations （Veterinary Drugs — Antimicrobial Resistance）

 

    P.C. 2017-459 May 5, 2017

 

    His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30（1） （see footnote a） of the Food and Drugs Act （see footnote b）， makes the annexed Regulations Amending the Food and Drug Regulations （Veterinary Drugs — Antimicrobial Resistance）。

 

    Regulations Amending the Food and Drug Regulations （Veterinary Drugs — Antimicrobial Resistance）

 

    Amendments

 

    1 Subsection C.01.001（1） of the Food and Drug Regulations （see footnote 1） is amended by adding the following in alphabetical order

 

    List A means the document, entitled List of Certain Antimicrobial Active Pharmaceutical Ingredients, that is published by the Government of Canada on its website, as amended from time to time; （Liste A）

 

    List B means the document, entitled List of Certain Veterinary Drugs Which May Be imported But Not Sold, that is published by the Government of Canada on its website, as amended from time to time; （Liste B）

 

    List C means the document, entitled Veterinary Health Products, that is published by the Government of Canada on its website, as amended from time to time; （Liste C）