Requirements for RegistrationClassification and ApplicationDossiersof Chemical Drugs
一、化學藥品注冊分類I. Registration classification of chemicaldrugs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 chemicaldrugs covers innovative drugs, modified newdrugs, generic drugs and chemical drugsmarketed overseas but not in China, whichfall 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 beenmarketed in China or overseas. They referto drugs that contain new compounds withclear 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 notbeen marketed in China or overseas. Theyrefer to drugs that have their structure,dosage form, formulation and process, routeof administration and indications optimizedon the basis of known active ingredients andhave 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 isomerof known active ingredients obtained byresolution or synthesis, or esterification of known active ingredients, or salification ofknown active ingredients (including saltcontaining hydrogen bonds or coordinationbonds), or change in acid group, basicgroup, or metallic element of knownactive ingredients of salt, or formation ofother non-covalent bond derivatives (e.g.,complex, chelate or clathrate), and havesignificant 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 activeingredients with new dosage form (includingnew drug delivery system), new formulationprocess or new route of administration, andhave 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 thatcontain known active ingredients and havesignificant 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 containknown 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 domesticapplicants by imitating the original drugsthat have been marketed overseas but not yetin China. Such drugs shall have the qualityand efficacy consistent with the referencelisted 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 domesticapplicants by imitating the original drugsthat have been marketed in China. Suchdrugs shall have the quality and efficacyconsistent 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 marketedoverseas and are under application for beingmarketed 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 thathave been marketed overseas and are underapplication for being marketed in China.Modified drugs shall have obvious clinicaladvantages.5.2境外上市的仿制藥申請在境內上市。5.2 Generic drugs that have been marketedoverseas and are under application for beingmarketed 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 beenfirstly approved tobe marketed in China andoverseas and have complete and sufficientsafety and effectiveness data as the basis forbeing 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 referencedrugs used in the R&D of generic drugs thathave been evaluated and confirmed by NMPA.The selection and promulgation of referencelisted drugs shall be performed according tothe relevant regulations of NMPA.二、相關注冊管理要求II. Relevant registration managementrequirements（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 innovativedrugs that contain new compounds with
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