DRUG REGISTRATION REGULATION
(SFDA Order 28)
(Translation by RDPAC, for Member use only)
Drug Registration Regulation was approved on June 18, 2007 by SFDA executive meeting and is hereby published, which become effective from October 1, 2007.
SFDA Commissioner
属兔子Shao Minli
July 10, 2007 DRUG REGISTRATION REGULATION
Chapter 1:  General Principles
Article 1:  This Regulation is promulgated according to the Drug Administration Law of The People’s Republic of China(Drug Administration Law), Administrative Licensing Law of The People’s Republic of China(Administrative Licensing 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 and / or importation, as well as the drug approval review, 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 the approval via a special process of innovative new drugs, those for difficult to treat and life threatening diseases.
Article 5:  The State Food and Drug Administration (SFDA) is the competent national authority for drug registration, responsible for the review and approval of clinical studies, production and importation of drugs.
Article 6:  Drug registration should follow the principles of openness equality, fairness, and for the convenience of the publics.
During drug registration, SFDA shall apply the systems of joint responsibility of the presiding reviewer, public disclosure and rescuing of the related staff, responsibility investigation for any wrongdoing, in order to administer the steps from acceptance, inspection, review, approval, through delivery, and subject to monitoring by the publics.
Article 7:During drug registration, should the drug administrative authority consider any permitting issues of significant interest to the publics, the issues should be announced to the publics and public hearing should be held.
Should the administrative permitting be related to any significant interest between applicant and other parties, before any decision is made, drug administration authorities should notify applicant and other parties of their entitlement to requesting hearings, statement and defending.
Article 8:Drug administration authorities shall provide applicant with accessible information regarding drug registration acceptance, inspection, test, evaluation, approval progress and conclusion and so on.
Drug administration authorities should publicly disclose the following information at the official website and / or office location.
1.Drug registration application items, procedure, fee
standards and basis, timeline, table of content of all required dossier, as well as reference application documents.
2.name list and the related information of the staff at each
steps from acceptance, inspection, test, review, through
approval.
formulary of the approved drugs.
企业成本核算
Article 9:The drug administration authority, units and staffs involved shall assume the responsibility of protecting the technical secrets and data provided by applicants during the process of drug registration.
Chapter 2:  Basic Requirements
Article 10:  A drug registration applicant (applicant) means an institution that makes drug application and assumes corresponding liability for drug registration.
A local applicant shall be a legally registered institution in China and be competent to independently assume legal liability.
A foreign applicant shall be    a legally established pharmaceutical company outside of China. In making application for an imported 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.
Article 11:Drug registration application includes application for new drug, generic drug applications, application for imported drug, supplemental application, as well as re-registration application.
A local applicant shall make application according to new drug or generic drug applications; a foreign applicant shall make application according to imported drug.
se535Article 12:  A new drug application means a registration application for a drug that has not been marketed in China.  Applications made for a change in dosage form, or route of administration, additional new indication of drugs shall be made according to new drug registration procedure.
Generic drug application means application for registration of a drug for which SFDA has already issued formal standards,
however, application of biological products shall be follow new drug application.
黄金好还是铂金好
Application for imported 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, generic drug applications, or imported drug.
A re-registration application means the application to continue the drug production or importation after the expiry of the certified drug approval documents.
Article 13:  Applicants should provide sufficient and reliable research data to evidence the safety, effe
ctiveness and quality control of the drugs, and assume liability of the truthfulness of the entire dossier.
Article 14:  In citing literature and materials, the name of the work(s) and journal(s) as well as volume, issue and page number shall be provided in the application dossier submitted for drug registration. For unpublished literature and materials, an authorization letter from the owner must be provided. For any foreign language materials a Chinese translation should be provided in accordance with relevant requirements.
Article 15:  SFDA shall implement the National pharmaceutical industry development plan and policy, and may organize an assessment of the benefit of introduction of drugs to the market.
Article 16:  During drug registration, drug administration authorities should conduct on site inspection and inspection chosen from decision of the pre-clinical study and clinical trials, as well as conduct on site inspection of production site prior to any marketing approval, in order to confirm the truthfulness, accuracy and completeness of the application dossier.
Article 17:  If two or more institutions jointly apply for drug registration, the application shall be made to the PDA where the drug manufacturer is located. If all the applicants are
美国重返亚太
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 18:  Regarding the drug or its formula, production process, 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 stating that the drug will not infringe on the patent rights of others. Upon acceptance of the application, drug administration authorities should publicly disclose the statement submitted by applicant.
If an infringement dispute occurs during registration application, the parties shall resolve the matter according to relevant laws for patent administration.
Article 19:  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, issue a drug approval number, Imported Drug License or Drug Product License, for an application that meets requirements.
刘文静
Article 20: According to Article 35 of Implementation Regulation, for a period of 6 years from the date
of the original applicant's approval, SFDA shall not approve a subsequent application that used, without the express consent of the original applicant, the undisclosed R&D data and other data generated by the original applicant for submission of application of manufacturing or marketing of a drug containing new chemical ingredients, unless the submitted data is generated by the subsequent applicant itself.
Article 21:The scope of pre-clinical laboratory study (pre-clinical study) of a drug for registration includes synthetic process, extraction methods, physical-chemical properties and purity, dosage form selection, screening of formulas, preparation process, inspection methods, quality specification, stability, pharmacology, toxicology and pharmacokinetic study. For TCM preparations, information such as the source and the processing of raw materials should