Chapter II

Application for Drug Registration

Article 10 An applicant for drug registration (hereinafter referred to as applicant) refers to the institution that submits a drug registration application and assumes corresponding legal liability.

A domestic applicant shall be an institution legally registered within the territory of People's Republic of China that independently assumes civil liability and an overseas applicant shall be a legal overseas drug manufacturer. Where an overseas applicant applies for import drug registration, it shall be done by its branch or entrusted agency within the territory of People's Republic of China.

The persons who handle the application for drug registration shall have professional knowledge and be familiar with the laws and regulations on, and the technical requirements for, drug registration.

Article 11 Drug registration applications include applications for new drugs, generic drugs, import drugs and their supplementary applications as well as re-registration applications.

Applications of domestic applicants shall be handled according to the procedures and requirements for new drugs or generic drugs, whereas applications of overseas applicants shall be handled according to those for import drugs.

Article 12 Application for new drugs refers to application for registration of drugs that have not been marketed within the territory of People's Republic of China.

Application for changing dosage form or route of administration, or claiming a new indication for marketed drugs, shall be submitted as the process of new drug application.

Application for generic drugs refers to registration application for producing the drugs having existing national drug standard which is approved to be marketed by the State Food and Drug Administration, whereas the application for biological products shall be submitted as the process of new drug application.

Application for import drugs refers to registration application for drugs manufactured abroad to be marketed within the territory of the People's Republic of China.

Supplementary application refers to application for variation, addition, or cancellation of the items or contents approved in the original application for new drug, generic drug or import drug.

Re-registration application refers to application for continued production or importation of a drug after the expiration of the valid term of the drug approval document.

Article 13 The applicant shall provide sufficient and reliable research data to prove the safety, efficacy and quality of the drug, and be liable for the authenticity of all the dossiers submitted.

Article 14 The cited literature of the dossier of drug registration shall indicate the title of works or the name, volume number, issue and page of the journal. Where the cited references are not published, an author's permission shall be provided. For foreign literatures, Chinese translation shall be provided as required.

Article 15 The State Food and Drug Administration shall obey the development plan and policies on the pharmaceutical industry constituted by the State, and may conduct assessment to the market value of drugs.

Article 16 In the process of drug registration, the drug regulatory department shall conduct on-site inspection and causal inspection to the non-clinical studies and clinical trials, as well as production site inspection for the pre-marketing approval to confirm the authenticity, precision and integrity of the dossier submitted.

Article 17 Where two or more institutions jointly apply for drugs, the application shall be submitted to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, in which the drug manufacturer is located; where the applicants are all drug manufacturers, the application shall be submitted to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, in which the manufacturer of pharmaceutical preparations is located; where none of the applicants is a drug manufacturer, the application shall be submitted to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, in which the site for pilot production of drug samples is located.

Article 18 An applicant shall provide the information on patent and its ownership of the applicant or other parties in China, in respect of the drug applied for registration, its formula, manufacturing processes and/or uses, etc. Where another party owns the patent in China, the applicant shall provide a statement of non-infringement. The drug regulatory department shall publish the information or the statement submitted by the applicant on its official website.

Where a patent dispute occurs in the process of drug registration, it shall be settled in accordance with relevant laws and regulations on patent.

Article 19 For a drug patented in China, applicants other than the patentee may submit the application for registration two years prior to the expiry date of the patent. The State Food and Drug Administration shall review the drug application in accordance with the Provisions, and after the expiry date of the patent, check and issue the drug approval number, Import Drug License or a Pharmaceutical Product License if the application conforms with the provisions.

Article 20 In accordance with the provisions in Article 35 of the Regulations for Implementation of the Drug Administration Law, where a manufacturer or distributor submits undisclosed drug experimental and other data which are independently acquired in order to obtain approval for production or marketing of the drug in question which contains any new chemical entity, the State Food and Drug Administration shall, within six years from the approval date of the drug, reject any application made by any other applicants by using the undisclosed data of the drug in question without permission of the original applicant who has obtained the drug approval, unless the data submitted are independently acquired by the applicants other than the original one.

Article 21 Pre-clinical drug study for drug registration application includes drug synthetic processes, extraction methods, physical and chemical properties, purity, selection of dosage form, screening of formula, preparing processes, testing methods, quality specifications, stability, pharmacology, toxicology and animal pharmacokinetics, etc. For traditional Chinese medicine preparations, in addition to the above-mentioned items, pre-clinical drug study also includes the study in the source of the crude drugs, and of their pre-treatment and processing, etc. For biological products, it also includes study on the source, quality specifications, storage conditions, biological characteristics and genetic stability of the starting materials such as bacterial and viral seeds/strains, cell lines, bio-tissues, and immunological study, etc.

Article 22 A pre-clinical drug study shall be in conformity with relevant requirements, among which the Good Laboratory Practice for Non-Clinical Laboratory Studies shall be implemented in the study of safety evaluation.

Article 23 The drug research institution shall have relevant staff, premises, equipment, instruments and management system, which are appropriate to the research project, and ensure the authenticity of all experimental data. Experimental animals, reagents and raw materials used in the study shall conform with the provisions of the State.

Article 24 An applicant who entrusts other institutions with a drug research, individual experiment, testing, or pilot production, etc. shall conclude a contract with the trustee, and state it clearly in the registration application. The applicant shall be responsible for the authenticity of the research data in the application dossier.

Article 25 Where the application is only for registration of pharmaceutical preparations, any drug substance used for the study shall have a drug approval number, an Import Drug License or a Pharmaceutical Product License, and be acquired through legitimated means. Where a drug substance used for the study has no drug approval number, Import Drug License or Pharmaceutical Product License, the use of drug substance in study shall be approved by the State Food and Drug Administration.

Article 26 The research data in application dossier for drug registration provided by an overseas drug research institution shall be attached with the items and pages of the information, and with notarized documents proving that the said drug research institution is legally registered overseas. The State Food and Drug Administration may send staff to conduct on-site inspection in needs of drug review.

Article 27 The drug regulatory department may request the applicant or the drug research institution responsible for testing to repeat the test based on the items, methods and data specified in the application documents, and may also authorize a drug testing institute or another drug research institution to repeat the test or conduct methodological verification.

Article 28 The drug study shall be conducted according to the relevant technical guidelines issued by the State Food and Drug Administration. Where an applicant conducts the study by adopting other evaluation methods and techniques, supporting data proving the scientific feasibility of such methods and techniques shall be provided.

Article 29 An applicant who obtains the drug approval number shall manufacture according to the manufacturing processes approved by the State Food and Drug Administration.

The drug regulatory department shall supervise and inspect the applicant's manufacture in accordance with the approved manufacturing processes and quality specifications.