国家食品药品监督管理局18日印发通知，摸底调查的内容包括出口原料药通用名称、药品批准文号、主要出口国家或地区、是否取得欧盟成员国药品生产质量管理规范证书等内容。

State food and drug administration, and issued by the notice,The content of the baseline survey include export API generic names/Drug approval number/The main export countries or regions/Whether get eu member states pharmaceutical production quality management standard certificate, etc.

　　专家表示，我国是化学原料药的生产和出口大国，生产规模仅次于美国，原料药出口已居世界第一位。但由于我国出口的原料药质量良莠不齐、技术含量不高，频频遭遇国外反倾销、反垄断等贸易壁垒。此外，化工企业无需经过药监部门批准即可将其生产的大宗药用化学原料产品作为“原料药”销售，也给药品安全带来安全隐患。

Experts say,Our country is chemical API production and export large country,The scale of production after the United States,API export is the highest in the world first.But because China's export API quality the good and bad are intermingled/Technical content is not high,Frequently encountering anti-dumping/Antitrust and trade barriers.In addition,Chemical enterprise need not after the approval of the department of also can be the production of bulk pharmaceutical chemicals products as"API"sales,Also give drug safety bring safe hidden trouble.

　　根据我国相关规定，只有当化工企业“自发”向国家食品药品监督管理局申请其产品作为“原料药”生产并提供给制药企业时，该产品才会受到食品药品监管局的监管。而如果相关化工企业不提出这样的申请，则不在药监部门的监管范围之内。

According to China's relevant regulations,Only when the chemical enterprise"spontaneous"To the state food and drug administration for its products as"API"Production and supply the pharmaceutical enterprise,This product will by the food and drug supervision bureau of supervision.And if related chemical enterprise does not put forward to this application,Also is not within the scope of the supervision of the department.