政策法规

2010年12月-我国发布GB25596-2010《食品安全国家标准 特殊医学用途婴儿配方食品通则》,对一岁以内婴幼儿的医用食品做出规定。

2012年08月27日-卫生部根据《食品安全法》及其实施条例的规定,组织制定《食品安全国家标准 特殊医学用途配方食品通则》(征求意见稿),该标准编制与国际通行标准接轨,注重标准的可操作性,严格按食品安全国家标准要求编写。起草工作组收集国内相关国家标准,同时也参考欧盟、CODEX、美国、澳新等国家的相关标准,

2013年02月16日-卫生部根据GB17405-1998 《保健食品良好生产规范》、《药品生产质量管理规范》等实施条例,组织制定了《特殊医学用途配方食品良好生产规范》,相信以上两项标准正式颁布后,我国特殊医学用途配方食品的生产将有据可依,长期以来依赖进口、量少价高的局面将被打破。

In December 2010, China issued the National Standard on Food Safety: General Standard on Formula Foods for Special Medical Purposes for Infants (GB25596-2010), which specifies requirements for medical foods for infants of one year old or younger.

On Aug. 27, 2012, the Ministry of Health issued the National Standard on Food Safety: General Standard on Formula Foods for Special Medical Purposes (Draft for Comments) based on the Food Safety Law and its implementation regulations. This standard, worked out in strict accordance with national standards on food safety, is compatible with applicable international standards and highly executable. The drafters collected relevant national standards of China, and consulted relevant standards of EU, CODEX, USA, Australia, New Zealand and some other countries for reference.

On Feb. 16, 2013, the Ministry of Health issued the Good Manufacturing Practices for Foods for Special Medical Purposes based on such standards and regulations as Good Manufacturing Practices for Health-care Foods (GB17405-1998) and the Good Manufacturing Practices for Drugs. It is believed that these two standards will be effective production standards for FSMP products in China, and help to end the complete dependence on import and high price & low quantity in this field.