【中英对照】《化学药品注册分类及申报资料要求》（2020年第44号）

今年6月30日，国家药监局发布2020年第44号通告，通告明确规定化学药品注册分类和申报资料要求的实施时间，值得注意的是，自2020年10月1日起，药物临床试验、药品上市注册及化学原料药申请，需按照现行版《M4：人用药物注册申请通用技术文档（CTD）》格式编号及项目顺序整理并提交申报资料。

【译文来源：中国食品药品国际交流中心】

化学药品注册分类及申报资料要求

Requirements for Registration Classification and Application Dossiers of Chemical Drugs

一、化学药品注册分类

I. Registration classification of chemical drugs

化学药品注册分类分为创新药、改良型新药、仿制药、境外已上市境内未上市化学药品，分为以下5个类别：

The registration classification of chemical drugs covers innovative drugs, modified new drugs, generic drugs and chemical drugs marketed overseas but not in China, which fall into the following 5 categories:

1类：境内外均未上市的创新药。指含有新的结构明确的、具有药理作用的化合物，且具有临床价值的药品。

Class 1: Innovative drugs that have not been marketed in China or overseas. They refer to drugs that contain new compounds with clear structures and pharmacological effects, and have clinical values.

2类：境内外均未上市的改良型新药。指在已知活性成份的基础上，对其结构、剂型、处方工艺、给药途径、适应症等进行优化，且具有明显临床优势的药品。

Class 2: Modified new drugs that have not been marketed in China or overseas. They refer to drugs that have their structure, dosage form, formulation and process, route of administration and indications optimized on the basis of known active ingredients and have significant clinical advantages.

2.1含有用拆分或者合成等方法制得的已知活性成份的光学异构体，或者对已知活性成份成酯，或者对已知活性成份成盐（包括含有氢键或配位键的盐），或者改变已知盐类活性成份的酸根、碱基或金属元素，或者形成其他非共价键衍生物（如络合物、螯合物或包合物），且具有明显临床优势的药品。

2.1 Drugs that contain an optical isomer of known active ingredients obtained by resolution or synthesis, or esterification of known active ingredients, or salification of known active ingredients (including salt containing hydrogen bonds or coordination bonds), or change in acid group, basic group, or metallic element of known active ingredients of salt, or formation of other non-covalent bond derivatives (e.g., complex, chelate or clathrate), and have significant clinical advantages.

2.2含有已知活性成份的新剂型（包括新的给药系统）、新处方工艺、新给药途径，且具有明显临床优势的药品。

2.2 Drugs that contain known active ingredients with new dosage form (including new drug delivery system), new formulation process or new route of administration, and have significant clinical advantages.

2.3含有已知活性成份的新复方制剂，且具有明显临床优势。

2.3 New compound preparations that contain known active ingredients and have significant clinical advantages.

2.4含有已知活性成份的新适应症的药品。

2.4 Drugs for new indications that contain known active ingredients.

3类：境内申请人仿制境外上市但境内未上市原研药品的药品。该类药品应与参比制剂的质量和疗效一致。

Class 3: Drugs manufactured by domestic applicants by imitating the original drugs that have been marketed overseas but not yet in China. Such drugs shall have the quality and efficacy consistent with the reference listed drug.

4类：境内申请人仿制已在境内上市原研药品的药品。该类药品应与参比制剂的质量和疗效一致。

Class 4: Drugs manufactured by domestic applicants by imitating the original drugs that have been marketed in China. Such drugs shall have the quality and efficacy consistent with the reference formulations.

5类：境外上市的药品申请在境内上市。

Class 5: Drugs that have been marketed overseas and are under application for being marketed in China.

5.1境外上市的原研药品和改良型药品申请在境内上市。改良型药品应具有明显临床优势。

5.1 Original drugs and modified drugs that have been marketed overseas and are under application for being marketed in China. Modified drugs shall have obvious clinical advantages.

5.2境外上市的仿制药申请在境内上市。

5.2 Generic drugs that have been marketed overseas and are under application for being marketed in China.

原研药品是指境内外首个获准上市，且具有完整和充分的安全性、有效性数据作为上市依据的药品。

Original drugs refer to drugs that have been firstly approved to be marketed in China and overseas and have complete and sufficient safety and effectiveness data as the basis for being marketed.

参比制剂是指经国家药品监管部门评估确认的仿制药研制使用的对照药品。参比制剂的遴选与公布按照国家药品监管部门相关规定执行。

Reference listed drugs refer to the reference drugs used in the R&D of generic drugs that have been evaluated and confirmed by NMPA. The selection and promulgation of reference listed drugs shall be performed according to the relevant regulations of NMPA.

二、相关注册管理要求

II. Relevant registration management requirements

（一）化学药品1类为创新药，应含有新的结构明确的、具有药理作用的化合物，且具有临床价值，不包括改良型新药中2.1类的药品。含有新的结构明确的、具有药理作用的化合物的新复方制剂，应按照化学药品1类申报。

(1) Class 1 chemical drugs are innovative drugs that contain new compounds with