【中英對照】《化學藥品注冊分類及申報資料要求》（2020年第44號）

今年6月30日，國家藥監(jiān)局發(fā)布2020年第44號通告，通告明確規(guī)定化學藥品注冊分類和申報資料要求的實施時間，值得注意的是，自2020年10月1日起，藥物臨床試驗、藥品上市注冊及化學原料藥申請，需按照現(xiàn)行版《M4：人用藥物注冊申請通用技術文檔（CTD）》格式編號及項目順序整理并提交申報資料。

【譯文來源：中國食品藥品國際交流中心】

化學藥品注冊分類及申報資料要求

Requirements for Registration Classification and Application Dossiers of Chemical Drugs

一、化學藥品注冊分類

I. Registration classification of chemical drugs

化學藥品注冊分類分為創(chuàng)新藥、改良型新藥、仿制藥、境外已上市境內未上市化學藥品，分為以下5個類別：

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類：境內外均未上市的創(chuàng)新藥。指含有新的結構明確的、具有藥理作用的化合物，且具有臨床價值的藥品。

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類：境內外均未上市的改良型新藥。指在已知活性成份的基礎上，對其結構、劑型、處方工藝、給藥途徑、適應癥等進行優(yōu)化，且具有明顯臨床優(yōu)勢的藥品。

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學異構體，或者對已知活性成份成酯，或者對已知活性成份成鹽（包括含有氫鍵或配位鍵的鹽），或者改變已知鹽類活性成份的酸根、堿基或金屬元素，或者形成其他非共價鍵衍生物（如絡合物、螯合物或包合物），且具有明顯臨床優(yōu)勢的藥品。

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劑型（包括新的給藥系統(tǒng)）、新處方工藝、新給藥途徑，且具有明顯臨床優(yōu)勢的藥品。

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復方制劑，且具有明顯臨床優(yōu)勢。

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適應癥的藥品。

2.4 Drugs for new indications that contain known active ingredients.

3類：境內申請人仿制境外上市但境內未上市原研藥品的藥品。該類藥品應與參比制劑的質量和療效一致。

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類：境內申請人仿制已在境內上市原研藥品的藥品。該類藥品應與參比制劑的質量和療效一致。

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類：境外上市的藥品申請在境內上市。

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

5.1境外上市的原研藥品和改良型藥品申請在境內上市。改良型藥品應具有明顯臨床優(yōu)勢。

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境外上市的仿制藥申請在境內上市。

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

原研藥品是指境內外首個獲準上市，且具有完整和充分的安全性、有效性數(shù)據(jù)作為上市依據(jù)的藥品。

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.

參比制劑是指經國家藥品監(jiān)管部門評估確認的仿制藥研制使用的對照藥品。參比制劑的遴選與公布按照國家藥品監(jiān)管部門相關規(guī)定執(zhí)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、相關注冊管理要求

II. Relevant registration management requirements

（一）化學藥品1類為創(chuàng)新藥，應含有新的結構明確的、具有藥理作用的化合物，且具有臨床價值，不包括改良型新藥中2.1類的藥品。含有新的結構明確的、具有藥理作用的化合物的新復方制劑，應按照化學藥品1類申報。

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

欧美黑几把操_亚洲无码精品中文字幕_日本中文字幕成年_五月丁香婷婷成人网_国产三级在线看_惠民福利国产免费AV片在线看观看_在线播放亚洲综合_亚洲国产一区久久_日韩欧精品码视频无删_免费人妻无码不卡中文字幕系

【中英對照】《化學藥品注冊分類及申報資料要求》（2020年第44號）