中新网12月14日电 据国家食品药品监督管理局网站消息，为加强含牛黄等药材中成药品种监督管理，严格处方投料生产，日前，国家食品药品监督管理局发出通知，就有关事项做出明确。

December 14, according to the state food and drug administration website news,Containing bezoar in order to strengthen the supervision and administration of traditional Chinese medicine herbs such as varieties,Strict prescription feeding production,a,State food and drug administration issued a notice,To make clear the matters.

　　通知指出，对于国家药品标准处方中含牛黄的临床急重病症用药品种及其他剂型或规格，可以将处方中的牛黄固定以培植牛黄或体外培育牛黄等量替代投料使用，但不得使用人工牛黄替代。通知附件所列品种及其他剂型或规格的现行药品标准中处方项下为人工牛黄的，相关生产企业应按修订药品标准的程序和要求于2013年12月31日前提出补充申请，并由国家药典委员会审定。自国家食品药品监督管理局批准之日起，相关生产企业不得继续使用人工牛黄投料生产。

Notice points out that,For the national drug standard prescription containing bezoar clinical urgent heavy sickness drug varieties and other dosage forms or specification,Can the bezoar fixed prescription to cultivate bezoar or in vitro cultivation bezoar equivalent replacement feeding use,But shall not use artificial bezoar alternative.Notice the annex varieties and other dosage forms or specifications of the standard of drug prescription for the artificial bezoar,Related production enterprise shall be revised according to the drug standard procedures and requirements in December 2013 and proposed by supplementary application,And the state pharmacopoeia committee approved.Since the state food and drug administration, the date of approval,Related production enterprise may not continue to use artificial bezoar feeding production.

　　通知明确，允许使用天然麝香投料生产的品种及企业，应符合国家林业局、国家工商行政管理总局和国家食品药品监督管理局的相关要求，并按要求进行专用标识管理。凡生产中使用培植牛黄、体外培育牛黄、人工牛黄替代牛黄，以及使用人工麝香替代天然麝香的品种，其说明书及标签中【成份】项下应准确标明培植牛黄、体外培育牛黄、人工牛黄或人工麝香；涉及说明书及标签变更的，应按要求向所在地省(区、市)食品药品监督管理部门备案。

Notice clear,Allows the use of natural musk feeding production of varieties and enterprise,Should comply with the state forestry administration/The state administration for industry and commerce and the state food and drug administration requirements,And according to the requirements of special identification management.In the production of all use cultivation bezoar/In vitro cultivation bezoar/Artificial bezoar alternative bezoar,And use artificial musk instead of natural musk varieties,The specification and tag[ingredients]Item should be accurately indicate the cultivation bezoar/In vitro cultivation bezoar/Artificial bezoar or artificial musk;Involved in manual and label change,According to the requirements should be to the local province(area/city)The food and drug supervision and administration department for the record.

　　通知要求，药品生产企业应严格按照药品标准投料生产，严禁擅自以其他药材或原料等替代。各省(区、市)食品药品监督管理部门应将上述要求及时通知本行政区域内相关药品生产企业，并督促做好有关工作，切实加强监督管理。

Notice requirements,Pharmaceutical producing enterprises shall be in strict accordance with the drug standard feed production,Strictly forbid to other materials or materials substitution.provinces(area/city)The food and drug supervision and administration department shall timely notify the above requirements within their respective administrative areas related pharmaceutical production enterprise,And supervise the work well,Strengthen the supervision and management.