1 泰国的药品分类 Medicines are classified into two major groups: modern and traditional drugs . Modern Dru gs are further divided into four categories, namely 1) household remedies whose sales require no licence; 2) ready-packed drugs that can be sold in drugstores by nurses or other medical professionals; 3) dangerous drugs; and 4) specially controlled drugs. Dangerous drugs can be bought without a prescription but must be dispensed by pharmacists. Drugs which may possess a potentially harmful effect on health, if misused, will be listed in the last category whose sales require a prescription. Traditional dru gs are those intended to be used in indigenous or traditional medical care as monographed in the official pharmacopoeia of traditional medicines or those declared by the Minister of Public Health as traditional medicines or those permitted to be registered as traditional medicines. The control and registration of drugs in this group are less stringent than those for modern drugs. 2 泰国的药品注册程序 泰国的药品注册分为5 种情况：1）普通药品注册，即中国的6 类药（仿制药）注册申请；2）传统药注册，即泰药注册申请；3）新药注册：泰国的新药包括新化学实体、增加新适应症药物、新复方和采用新型释药系统的药物，其中新化学实体为原创新药，增加适应症、新复方和采用新型释药系统的药物为普通新药；4）生物制剂注册；5）草药注册。 2.1 普通药品注册 泰国的普通药品与我国的已有国家标准药品相对应，即仿制药，但是与中国不同的是，其注册比较简单，不需要进行生物等效性试验，符合已有标准即可，因此仅需进行质量研究。 其注册程序包括三个步骤：1） 生产或进口药品样品的许可申请；2） 药品质量控制和分析方法的批准申请；3） 药品注册许可证的申请。 2.2 传统药注册 传统药的注册申请相对比较简单，申请者仅需申请药品注册证，不需提交分析方法。 2.3 原创新药注册 新药注册是所有药品注册类型中最为严格的一种，泰国还专门成立了一个新药注册审批专家委员会...
