Administrative Measures for Drug Registration
Administrative Measures for Drug Registration
Administrative Measures for Drug Registration
Order of the State Food and Drug Administration No. 28
July 10, 2007
The Administrative Measures for Drug Registration, which were adopted at the executive meeting of the State Food and Drug Administration (SFDA) on June 18, 2006, are hereby promulgated and shall come into effect as of October 1, 2007.
Director: Shao Mingli
Administrative Measures for Drug Registration
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law), Administrative Licensing Law of the People's Republic of China (hereinafter referred to as the Administrative Licensing Law) and the Implementing Regulations of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Implementing Regulations) in order to ensure the safety, effectiveness and controllable quality of drugs and regulate the drug registration.
Article 2 These Measures shall apply to the application for drug clinical trials, drug production and import, as well as drug examination and approval, registration, inspection and administration within the territory of China.
Article 3 Drug registration means the examination and approval process through which a decision is made by SFDA, upon application of the registration applicant, to either approve or not approve the application of a drug to be marketed, based on a systematic examination of the safety, effectiveness and controllable quality of the drug.
Article 4 The State encourages the study and development of new drugs and exercise fast track approval for innovative new drugs and those for diseases difficult to be treated or diseases threatening life.
Article 5 SFDA, the competent national authority for drug registration, is responsible for the examination and approval of clinical trials, production and import of drugs.
Article 6 The open, fair and equitable principles shall be followed in drug registration.
SFDA adopts the chief reviewer collective responsibility system, the interested official publicity and evasion system, and accountability system for drug registration. The procedures covering acceptance, inspection, review, approval, and service shall be under supervision by the society.
Article 7 During the drug registration process, pharmaceutical regulatory departments shall announce to the public the major licensing matters that they consider involving public interests and shall hold hearings.
Where administrative licensing directly involves the major interest relationships between the applicants and the others, the pharmaceutical regulatory departments, prior to making administrative licensing, shall notify the applicants and the interested party that they are entitled to demand hearings, statements and defenses.
Article 8 The pharmaceutical regulatory departments shall provide the applicants with information including drug registration acceptance, inspection, testing, review and approval progress and findings which are available for inquiries. The pharmaceutical regulatory departments shall publicize the following information on the website of the executive authorities or in the places where applications for registration are accepted:
1. Drug registration application matters, procedures, charging standards and basis, time limit, catalogs of all the materials needed to be submitted and the model text of application; and
2. List of members conducting drug registration acceptance, inspection, testing, review, and approval as well as the relevant information; and
3. Comprehensive information including the directory of approved drugs.
Article 9 The pharmaceutical regulatory departments, relevant units and members participating in the drugs registration shall bear confidential liabilities for the technology secrets and experiment data submitted by the applicant.
Chapter II Basic Requirements
Article 10 A drug registration applicant (hereinafter referred to as an applicant) means an institution which makes application for drug registration and assumes the corresponding legal liability.
A domestic applicant shall be a legally registered institution within the territory of China that is competent to independently assume civil liabilities. A foreign applicant shall be a legally established pharmaceutical company outside the territory of China. In making application for registration of drug importation, a foreign applicant shall appoint its office within the territory of China, or authorize an agent within the territory of to carry out the application.
The personnel handling the drug registration shall have the corresponding professional knowledge, and be familiar with drug registration laws, regulations and technical requirements.
Article 11 Drug registration application includes application for registration of new drugs, generic drugs, imported drugs and the supplemental application thereof, as well as the application for re-registration.
An applicant within the territory of China shall make application for drug registration according to the procedures and requirements for new drugs and generic drugs; and an applicant outside the territory of China shall make application for imported drug registration according to those for imported drugs.
Article 12 A new drug application means a registration application for a drug that has not been marketed within the territory of China.
A drug that has been marketed in China for which a registration application is made for a change in dosage form, or route of administration, or adding new indication shall be reported according to those procedures for new drugs.
Generic drug application refers to the registration application for a drug that has been approved to be marketed by the SFDA and for which the national standard has been established. Biological products shall be reported in accordance with the new drug application procedures. Imported drug application refers to the registration application for drugs produced outside the territory of China and to be sold within the territory of China.
Supplemental application means the registration application for a change, addition, or cancellation of any original item or content after the approval of a new drug, generic drug, or imported drug.
Re-registration application refers to registration application made by the applicant who intends to continue production or import the drug after the expiration of the valid term of the approval certificate of the drug.
Article 13 The applicant shall provide adequate and reliable study data to prove the safety, effectiveness and controllable quality of the drug, and shall be responsible for the authenticity of all the information.
Article 14 Annotated book title, the name, volume, issue, and page number of the publication shall be notated if bibliographies are quoted in the materials submitted for drug registration. Permission to use the data issued by the material owner shall be provided for unpublished literature. Chinese version of foreign materials shall be provided in accordance with the requirements.
Article 15 The SFDA shall execute the drug industry development planning and industrial policy formulated by the State and may organize assessment of the marketing value of the drug.
Article 16 During the registration process of a drug, the pharmaceutical regulatory departments shall organize on-site inspection and reason inspection for non-clinical studies and clinical trials, as well as on-site inspection of production prior to approval for being marketed, so as to verify the authenticity, accuracy and completeness of the materials submitted.
Article 17 If two or more institutions jointly apply for new drug registration, the application shall be made to the pharmaceutical regulatory department of the province, autonomous region or municipality directly under the Central Government where the drug manufacturer is located. If all the applicants are manufacturers, the application shall be made to the pharmaceutical regulatory department of the province, autonomous region or municipality directly under the Central Government 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 pharmaceutical regulatory department of the province, autonomous region or municipality directly under the Central Government where the drug sample is pilot manufactured.
Article 18 The applicant shall, in respect of the drug applied for registration or the prescription, technology, and usage applied, provide explanation on the patent and its ownership status of the applicant or others in China. If other people have a patent in China, the applicant shall provide a statement that there is no infringement to others' patent. The pharmaceutical regulatory departments shall publicize the explanation or statement submitted by the applicant on the website of the executive authorities.
The relevant patent laws and regulations shall be applied to solve any patent dispute occurred during the drug registration process.
Article 67 During the monitoring period of a new drug, drug manufacture enterprise shall regularly inspect the production process, quality, stability, efficacy and adverse reaction, and annually report to the drug supervision and administration department of the local province, autonomous region or municipality directly under the Central Government. The drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government shall order an enterprise that fails to fulfill its responsibilities within the drug-monitoring period to take corrective measures.
Article 68 When any serious quality problem, or any serious or unexpected adverse reaction is discovered by an institutions of drug manufacture, distribution, use or inspection, or administration, it shall be reported to the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government in a timely manner. The drug supervision and administration department of the province, autonomous region or municipality under the Central Government shall organize an investigation and report to SFDA immediately.
Article 69 If production of a new drug with a monitoring period fails to begin within 2 years from the approval date, SFDA may approve the production application from another applicant for the new drug and continue to monitor it.
Article 70 After a new drug enters the monitoring period, for an application with clinical trial already been approved by SFDA to other applicant, the application may continue in the regular review process, and SFDA may approve the production or import of an application that is in compliance with the requirements, as well as monitor the new drug produced by the pharmaceutical manufacturer within the territory of China.
Article 71 After a new drug enters the monitoring period, application from another applicant for same-variety drugs shall not be accepted. For an application which has been accepted but with clinical study not been approved by SFDA, the application shall be returned. Upon the expiration of the monitoring period, another applicant may apply for generic drugs or imported drugs.
Article 72 An approved application for imported drug registration with clinical trial already been approved, may continue the regular examination process, and SFDA may approve the production of a drug with application that meets the requirements. The applicant may also withdraw the application and re-apply for generic drugs. An application which has been accepted but with clinical trial not been approved, the application shall be returned and the applicant may re-apply for generic drugs.
Chapter V Application Examination and Approval of Generic Drugs
Article 73 The applicant of generic drugs shall be a drug manufacturer.
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