【正文】 ts in the existing registration approval of a new drug, drug already with national standards, or import drug. Article 9: Application for registration shall be made to PDA with submission of relevant documents and drug samples. However, application for import drug shall be made to SFDA. Applicant should assume the liability for the truthfulness of all the application dossier.. Article 10: If two or more institutions jointly apply for new drug registration, the application shall be made to the PDA where the drug manufacturer is located. If all the applicants are manufacturers, the application shall be made to the PDA where the drug manufacturer of the preparation is located. If none of the applicants is a drug manufacturer, the application shall be made to the PDA where the drug sample is pilot manufactured. Article 11: Regarding the drug or its formulation, manufacture processing, indication etc. the applicant shall submit documents explaining the China patent status and ownership rights. If other party holds patent in China, the applicant shall submit a letter of guarantee stating that the drug will not infringe on the patent rights of others and that the applicant assumes liability for any possible infringement. Article 12: If an infringement dispute occurs after pletion of registration, the parties shall try to negotiate a resolution, or resolve the matter according to relevant laws, regulations, or rules through judicial organs or patent administration institutions. Once there is a final rule from the Patent Administration or an enforcement judgment from People’ Court to determine the fact of infringement, Patent holder may apply at SFDA for cancellation of drug approval number of infringing party. SFDA shall based on the facts, cancel the certified drug approval of infringing party. Article 13: For a drug that has obtained patent protection in China, another applicant may apply for registration within two years prior to the patent expiration. SFDA shall review the application according to this Regulation and, after expiration of the patent, approve production or import for an application that meets requirements. Article 14: For a period of 6 years from the date of the original applicant39。serious adverse event was not timely reported。new drugs which treat diseases for which there is no effective therapy. Drugs needed for emergency.Article 49: After receipt of an application for a drug described in Article 48 of this Regulation, PDA shall examine and made remendations as to whether the application meets the requirements for fast track approval. Upon receipt of PDA remendations, SFDA shall then decide whether to use fast track approval for the drug application.Article 50: When a new drug is jointly developed, the application shall be made by one of the parties, and other parties shall not apply. When a joint application needs to be made, the application shall be signed by all the parties. Except for a drug described in Article and , after approval, the new drug shall only be manufactured by one party. Different strengths of one drug shall not be manufactured by different parties.No one should attempt to make different applicant to apply for registration for the same technology of new drug, or make repeat application in any way. SFDA and PDA will organize the related inspection, if any needs. Once the foresaid fact is confirmed, the application will not be accepted, and the application will be returned if already accepted. Article 51: During review process of new drug, even if the marketing approval of other domestic drug of the same active substance is approved overseas, the registration category 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 other domestic drug of the same active substance is approved in China, the registration category and technical requirements of the same kind of drug shall remain unchanged in the review process in China.Section 2: Approval of Clinical Study for New DrugsArticle 52: Upon the pletion of the preclinical study, the applicant shall plete the Application Form for Registration of New Drugs, and submit the authentic materials and sample drugs to PDA.Article 53: PDA shall examine for form the application dossier, and if the requirement are met, the application will be accepted with issuing of acceptance notification of drug registration application. If the requirements are not met, the application will not be accepted with issuing of nonacceptance notification of drug registration application, with explanation of reasons.PDA shall, within 5 days upon acceptance of the application, organize and conduct onsite inspection for production and research of the drug, take sample drugs of 13 batches, and notify the drug control institute for inspection. PDA shall, within the prescribed time limit, submit remendations, inspection report and application dossier to SFDA, and notify the applicant.Article 54: The drug control institute shall conduct drug inspections and drug standard inspection upon receiving notification, and submit the inspection reports to SFDA within the described time, notify the PDA which requested the inspection, and notify the applicant.Article 55: Upon receipt of the application dossier, SFDA shall organizes the pharmaceutical, medicals and other technical people to conduct technical review of the new drug, and SFDA may request the applicant to provide supplemental information and drug sample. When SFDA consider the requirements are met, Approval for Drug Clinical Study will be issued. When SFDA does not consider the requirements are met, Notification of Approval Opinion will be issued with explanation.Article 56: Upon receipt of verification remendation, if the drug control institute concludes that the quality cannot be c