【正文】 quality problems, SFDA or PDA may adopt emergency mandatory administrative measures to suspend or stop the clinical study, and the applicant and institutions must immediately stop the study.Article 44: A foreign applicant who wants to conduct an international multi–center clinical study shall apply at SFDA in accordance with the following provisions:1) The investigational drug used for an international multi–center clinical study shallbe one already registered in a foreign country or in phase II or phase III clinical trials. An application for an international multi–center clinical study of newpreventive vaccine from a foreign applicant still not registered outside China shall not be accepted by SFDA. 2) In approving an international multi–center clinical study in China, SFDA mayrequest the applicant to firstly conduct the Phase I clinical trials in China.3) During a study conducted in China, the Applicant shall, in accordance with the relevant regulations, report to SFDA any serious adverse events or unexpectedadverse events which occur in any countries.4) Upon the pletion of the study, the Applicant shall submit the plete clinical10/107/study report to SFDA.Drug Registration Regulation (SFDA Order 28)5) Data generated from an international multi–center clinical trial, if used for drug registration in China, shall be in accordance with the relevant provision of thisRegulation, and the applicant shall submit the plete research information ofthe study.Chapter 4: Application and Approval of New DrugsArticle 45: SFDA may use special approval process for the following new drug,where detail regulation will be promulgated separately:1) New drug material and its preparation, active ingredients and its preparation extracted from plant, animal and minerals, which have not been marketed in China and。2) chemical drug raw material and its preparations, and/or biological product that have not been marketed domestically or outside China。3) new drugs for AIDS, cancer and orphan disease that are superior to the marketed drugs.4) new drugs which treat diseases for which there is no effective therapy. For those drugs meeting the above provisions of this Regulation, during the drug registration, the applicant may apply for a special approval, SFDA shall organizespecialist meeting to decide whether to use special approval for the drug application. Detailed provisions of special approval shall be promulgated separately. Article 46: When a new drug is jointly developed, the application shall be made by one of the parties, and other parties shall not apply in repetition. When a jointapplication needs to be made, the application shall be signed by all the parties. Afterapproval, all the new drugs, including different strengths of the same drugs shall onlybe manufactured by one party. Article 47: For those registration applications of change in dosage form of drug butwith no change in route of administration, new technology should be used to improve drug quality and safety, and there should be obvious clinical advantage in paringwith original dosage form.Except for targeted delivery preparation, sustained or controlled release preparation, the registration applications of change in dosage form of drug but with no change in route of administration should be made by the pany with production condition.11/107/Drug Registration Regulation (SFDA Order 28)Article 48: During review process of new drug, even if the marketing approval ofother drug of the same active substance is approved overseas, the registrationcategory and technical requirements of the drug shall remain unchanged in the review process in China.During the review process of new drug, even when the marketing approval of otherdomestic drug of the same active substance is approved in China, the registrationcategory and technical requirements of the same kind of drug shall remain unchanged in the review process in China.Article 49: Drug applicanion dossier should be submitted in one time, the applicantshall not self submit supplemental technical material to SFDA once any application isaccepted, except for new information related to the drug safety or those specialapproval. If applicant considers the new technical materials must be added, theapplicant should withdraw the application. When an applicant reapply, the applicationprocedures of this regulation should be met and there should not be any same drugsalready entering into monitoring period.. Section 1: Clinical Trials for New DrugsArticle 50: Upon the pletion of the preclinical study, the applicant shallplete the Application Form for Registration of New Drugs, and submit the authentic dossier to the local PDA.Article 51: PDA shall examine the format of the application dossier, and if the requirements are met, the application will be accepted with issuing of acceptance notification of drug registration application. If the requirements are not met, theapplication will not be accepted with issuing of nonacceptance notification of drug registration application, with explanation of reasons.Article 52: PDA shall, within 5 days upon acceptance of the application, organize and conduct onsite inspection of the drug research and the original data, conductpreliminary examination of the application dossier. If the drug to be registered isbiological product, PAD shall take sample drugs of 3 batches, and notify the drug control institute for inspection.Article 53: PDA should, within the prescribed time limit, submit the examination remendation, verification report and application dossier to the Center of DrugEvaluation of SFDA, and notify the applicant.Article 54: Drug control institute received the registration inspection n