Chapter 1 General Provisions Article 1 In order to ensure the safety, effectiveness and quality control of drugs and standardize drug registration activities, in accordance with the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as "Drug Administration Law") "Law") and "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Implementation Regulations of the Drug Administration Law"), these Measures are formulated. Article 2 These Measures shall apply to those engaged in drug development and clinical research within the territory of the People's Republic of China, applying for drug clinical research, drug production or import, and conducting relevant drug registration inspection, supervision and management. Article 3 Drug registration refers to the systematic evaluation of the safety, effectiveness, quality controllability, etc. of drugs to be marketed in accordance with legal procedures, and making a decision whether to agree to conduct drug clinical research, produce drugs, or import drugs. The review and approval process includes the review and approval of the content stated in the application for change of drug approval documents and their attachments. Article 4 The state encourages the research and creation of new drugs, and implements rapid approval of new drugs created and new drugs for the treatment of difficult and critical diseases. Article 5 The State Drug Administration is in charge of national drug registration management and is responsible for the approval of drug clinical research, drug production and import.
The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government are entrusted by the State Drug Administration to review the completeness, standardization and authenticity of drug registration application materials. Article 6 A drug registration applicant (hereinafter referred to as the applicant) refers to an institution that submits a drug registration application, assumes corresponding legal responsibilities, and holds drug approval documents after the application is approved. Domestic applicants should be legal entities legally registered in China, and overseas applicants should be legal overseas pharmaceutical manufacturers. Overseas applicants shall handle the registration of imported drugs by their offices in China or by their entrusted agencies in China.
Personnel handling drug registration applications should be corresponding professional and technical personnel and be familiar with drug registration management laws, regulations and technical requirements. Chapter 2 Application for Drug Registration Article 7 Application for drug registration includes applications for new drugs, applications for existing national standard drugs, applications for imported drugs and their supplementary applications. Domestic applicants shall apply for new drugs and existing national standard drugs, and overseas applicants shall apply for imported drugs. Article 8 New drug applications refer to registration applications for drugs that have not been marketed and sold in China. If the dosage form or route of administration of a marketed drug is changed, it shall be managed as a new drug.
An application for a drug that already has a national standard refers to an application for drug registration that produces formal standards promulgated by the State Food and Drug Administration.
Application for imported drugs refers to the registration application for drugs produced overseas to be marketed and sold in China.
Supplementary application refers to a new drug application, an application for an existing national standard drug, or an imported drug application that changes, adds, or cancels the original approved items or content after approval. If the drug registration application and approved clinical research application in the approval process need to be changed accordingly, as well as the transfer of new drug technology, the repackaging of imported drugs, and the correction of drug trial standards, they shall be handled as supplementary applications. Article 9 To apply for drug registration, the applicant shall submit it to the Food and Drug Administration of the province, autonomous region, or municipality directly under the Central Government where it is located, and submit relevant information and drug samples; for application for registration of imported drugs, the applicant shall submit it to the State Food and Drug Administration. Article 10 If two or more units are simultaneously applicants for new drugs, they shall submit an application to the Food and Drug Administration of the province, autonomous region, or municipality directly under the Central Government where the drug manufacturer is located; if the applicant units are both drug manufacturers, they shall apply to the applicant for the preparation. The drug regulatory bureau of the province, autonomous region, or municipality directly under the Central Government where the drug manufacturer is located shall submit an application; if the applicant is not a drug manufacturer, it shall submit an application to the drug regulatory bureau of the province, autonomous region, or municipality directly under the Central Government where the sample trial production site is located. Article 11 The applicant shall provide a description of the patent in China and its ownership status for the drug applied for registration or the prescription, process, etc., and submit a letter of guarantee that it will not infringe the patent of others, and promise to take full responsibility for possible infringement. Responsible for the consequences. Article 12 If a patent dispute arises after the application for drug registration is approved, the parties shall resolve it through negotiation on their own, or through judicial organs or patent administrative organs in accordance with the provisions of relevant laws and regulations.
Article 13 For a drug that has obtained a Chinese patent, other applicants may apply for registration within 2 years before the expiration of the drug patent. The State Food and Drug Administration will review the product in accordance with these Measures and, if it meets the regulations, will approve production or import after the patent expires. Article 14 In accordance with the provisions of Article 35 of the "Regulations for the Implementation of the Drug Administration Law", self-obtained and undisclosed test data and other data submitted by manufacturers or sellers who have obtained a license to produce or sell drugs containing new chemical ingredients , within 6 years from the date of approval of the license, the National Medical Products Administration will not approve other applications that use undisclosed data without the consent of the applicant who has obtained the license. However, other applicants who submit self-obtained data are excluded.
When applying for drug registration, other applicants should promise that all test data are obtained by themselves and ensure their authenticity. Article 15 If a pharmaceutical manufacturer accepts the entrustment of an overseas pharmaceutical manufacturer to process drugs in my country but does not sell or use them within the country, the domestic drug manufacturer that performs the processing shall submit an application to the drug regulatory administration of the province, autonomous region, or municipality directly under the Central Government where it is located. If the regulations are met, the drug regulatory administration of the province, autonomous region, or municipality directly under the Central Government will approve it, but will not issue a drug approval number.