【正文】 28Chapter 16: Miscellaneous 29Annex 1: Registration Categories and Application Information Requirements of TCM and Natural Drugs 31Annex 2: Registration Categories and Application Information Requirements of Chemical Drugs 32Annex 3: Registration Categories and Application Information Items Requirements of Biological Products 48Annex 4: Registration Items and Application Information Requirements of Supplemental Application of Drug Registration 68Annex 5: Application Information Items of Drug ReRegistration 80Chapter 1: General PrinciplesArticle 1: This Regulation is promulgated according to the Drug Administration Law of The People’s Republic of China (Drug Administration Law) and the Implementing Regulation of the Drug Administration Law of The People’s Republic of China (Implementing Regulation) to ensure the safety, efficacy and quality control of drugs and standardize drug registration.Article 2: This Regulation shall apply to all drug research and clinical studies, application for clinical study, drug production or importation, as well as the related drug registration inspection and drug administration in The People’s Republic of China (PRC).Article 3: Drug registration means the legal process by which a decision is made by SFDA, upon application of registration applicant, to either approve or not approve the conducting of a drug clinical trial, production or importation of a drug to be marketed, based on a systematic evaluation of the safety, efficacy and quality control of the drug. Article 4: The State shall encourage research and development of new drugs and exercise fast track approval for innovative new drugs, those for difficult to treat and life threatening diseases, and drugs needed for emergency use.Article 5: The State Food and Drug Administration (SFDA) is the petent national authority for drug registration, responsible for the review and approval of clinical studies, production and importation of drugs. Provincial Drug Authorities (PDA) shall be authorized by SFDA to examine the pleteness, standardization and authenticity of an application dossier, and organize inspection of the pilot manufactured drugs. Article 6: A drug registration applicant (applicant) means an institution which makes application for and assumes corresponding liability for drug registration, and holds the drug approval certificate after approval has been obtained. A local applicant shall be a legally registered institution in China and be petent to independently assume legal liability. A foreign applicant shall be a legally established pharmaceutical pany outside of China. In making application for an import drug registration, the foreign applicant shall use its office in China, or authorize an agent in China to handle the application.The person(s) handling the drug registration application shall have technical expertise, and be familiar with drug administration laws, regulations and technical requirements. Chapter 2: Application for Drug RegistrationArticle 7: Drug registration application includes application for new drug, application for a drug already with national standards, and application for import drug as well supplemental application. A local applicant shall make application according to new drug or a drug already with national standards。 a foreign applicant shall make application according to import drug.Article 8: A new drug application means a registration application for a drug that has not been marketed in China. A drug that has been marketed in China for which an application is made for a change in dosage form, or route of administration, add new indication shall be treated as a new drug applicationApplication for a drug already with national standards means application for production of a drug for which SFDA has already issued formal standards.Application for import drug means application for a drug produced outside China to be marketed in China.Supplemental application means an application for the change, addition, or cancellation of any item or contents 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