Article 1 in order to ensure the drug safety, effectiveness and quality control, regulate the drug registration, according to "Drug Administration Law of the people's Republic of China" (hereinafter referred to as the "Drug Administration Law"), "the people's Republic of China Administrative Licensing Law" (hereinafter referred to as the "administrative licensing law"), "the people's Republic of China drug administration regulations for the implementation of the law" (hereinafter referred to as the"Regulations" the implementation of the pharmaceutical administration law), the enactment of this approach.
Article second apply for drug clinical trials, drug production and drug imports in the territory of the people's Republic of China, as well as the drug approval, registration inspection and supervision and management, the application of this approach.
Article third drug registration, refers to the State Food and drug administration according to the provisions for drug registrationapplication, in accordance with the statutory procedures for review, to be marketed drug safety, effectiveness, qualitycontrollability, and decide whether to grant the approval processand its application.
Article fourth country to encourage research and development of new drugs, new drugs, new drugs for new treatment ofcomplicated and serious diseases and carry out special approval.
Article fifth the State Food and Drug Administration in charge of national drug registration work, responsible for the examination and approval of clinical trial of drugs, drug production and imports.
Article sixth drug registration shall follow the principle of openness, fairness, impartiality.
The State Food and drug administration to implement thecollective responsibility, relevant personnel publicity system andchallenge system, the accountability system for drug registration,inspection, acceptance, review, approval, and other links toaccept social supervision.
Article seventh in the drug registration process, the pharmaceutical supervisory and administrative department thatmajor licensing matters involving the public interests, it shall make a public announcement, and hold a hearing.
Administrative license directly involves the vital interests betweenthe applicant and others, the pharmaceutical supervisory and administrative department before making a decision on administrative license, it shall inform the applicant, interested party of the right to request a hearing, the rights of statement and averment.
Eighth if a pharmaceutical supervisory and administrative department shall provide inquiry, examination, inspection andacceptance of drug registration, review, examination and approval to the applicant's progress and results and other information.
The pharmaceutical supervisory and administrative departmentsshall be in the administrative organs or public site acceptance of the application for registration of the following information:
(a) application, procedure, charge standard and basis, the time limit for drug registration, need to submit the catalogue of all materials and application demonstration version;
(two) for drug registration, inspection, test, acceptance review,approval list all aspects of personnel and related information;
(three) approved drugs directory information.
Ninth if a pharmaceutical supervisory and administrative department, the relevant units and personnel involved in the drug registration, technical secrets and experimental data submitted by the applicant shall be obliged to keep confidential any.