1、he and pages of the submitted materials by the foreign drug research institution and governmental document proving its lawful foreign registration shall be attached. After authentication by SFDA the documents can be used as the application materials. SFDA may send people to do an on-site inspection,
2、 if necessary. 4Clinical Study of Drugs Clinical study of drugs includes clinical trials and bioequivalence trials and shall be conducted according with of Good Clinical Practice (GCP). An applicant for new drug registration shall conduct clinical trials or bioequivalence trials. 5Applic ation and A
3、pprov al of New Drugs Only after finishing clinical trials or bioequivalence trials may an application be made for a new drug certificate, new drug production or importation. Only an applicant which meets production qualifications or conditions shall be issued a new drug certificate and drug approva
4、l number. An applicant which does not meet product qualifications or conditions, which has not been confirmed as a drug production enterprise, may only apply for a new drug certificate. Note: Source from SFDA Main Content Date10Confidential, Copyright2003 by Sinotrust Hisamitsu China Market Entry St
5、rategy Drug registration regulation (continued) Chapter NO. Chapter TitleMain Content 6 Applic ation and Approv al of Drugs Admitt ed with Nation al Standa rds For an abbreviated drug registration application, the applicant shall complete pilot production in according to relevant technical requireme
6、nts, complete the Form for Abbreviated Application of Drugs and submit relevant technical materials to the provincial drug administration authorities (where the production facility is located). 7 Applic ation and Approv al for OTC Drugs OTC drugs subject to this Regulation include new preparations a
7、nd new combination formulations developed from active components of the OTC drugs determined by SFDA or, OTC drugs not yet marketed in China but marketed abroad, and OTC drugs with national (Chinas) drug standards. For an OTC drug that has not been marketed in China, a new drug application shall be
8、filed, for an OTC drug which already has national standards, an abbreviated application shall be filed. 8 Suppl ementa ry Applica tion for Drug Registr ation The original applicant should submit a supplementary application in the following situations: Changes related to drug production, Changes in q
9、uality standard, Changes related to drug use and others. 9New Drugs Techno logy Transf er New drug technology transfer refers to the process whereby the owner of new drug certificate transfers its new drug processing technology to a pharmaceutical production enterprise. The transfer of new drug tech
10、nology shall generally only have a New Drug Certificate without a drug approval number. Generally, the new drug technology may only be transferred once and the transferee enterprise may not retransfer the technology. 10Approv al of Toll Manufa cturing and Repac kaging A foreign pharmaceutical manufa
11、cture which has obtained an Import Drug Certificate or Pharmaceutical Product Certificate which wants to authorize a local pharmaceutical production enterprise to repackage its drug must provide its China patent certificate. Note: Source from SFDA Main Content Date11Confidential, Copyright2003 by Si
12、notrust Hisamitsu China Market Entry Strategy Drug registration regulation (continued) Chapter NO. Chapter TitleMain Content 11Adminis tration of Testing for Drug Registra tion Testing must be conducted for drug registration. Testing includes testing of sample products of the drug for which registra
13、tion application is made and inspection of the drugs quality standards. 12Adminis tration of Drug Registra tion Standar ds A drug registration standard refers to the standards approved by SFDA for the specific drug of the applicant. The drug registration shall not be lower than national 的扩张与收缩、营运方式的转变、管理的变革等一系列变动。经营绩效：主要是指在外部环境发生变化的情况下，企业在经营利润、产品成本、市场份额等方面的变化趋势。 19 / 17 访问网址: /业务上保守，但在历史的资金融通手法上却很冒进”。五、 需要明确的问题 调查的基准日是
