The 110th change for new drug research and development, production of drugs and drug import approval documents and their attachments shall specify the matters, shall make supplementary application.

The tenth drug registration (hereinafter referred to as the applicant), refers to the application for registration of the drugs and bear the corresponding legal responsibility mechanism. A domestic applicant should be and can bear civil liabilities independently legally registered within the territory of China, an overseas applicant shall be a legal overseas drug manufacturer. Overseas applicants for registration of imported drugs, agency within China shall be composed of its offices in the territory of China or its authorized.

Clinical trials of thirtieth drugs (including the bioequivalence test), must be approved by the State Food and drug administration, and must implement the "drug clinical trial quality management standards". Pharmaceutical supervisory and administrative departments shall supervise and inspect the clinical trial approval.

Article forty-fifth the State Food and drug administration carried out the special approval of the following application can: (a) the effective ingredient and preparation extracted from the plant, animal, mineral and other substances in the not sold in the domestic market, newly discovered medicinal materials and their preparations;

The applicant shall be seventy-third generic drugs production enterprise, the application of drugs should be consistent with the scope of "drug production license" as the production.

Article 105th for generic drugs belonging to the non prescription drug management, the applicant shall be in the "drug registration application form" "additional items marked with" non prescription items.

170th Chinese medicine and natural medicine, chemical medicine, biological products, supplementary application, re registration application materials and requirements please refer to Annex 1, annex 2, Annex 3, Annex 4, Annex 5, Annex 6 Provisions monitoring period.

Article 120th the State Food and Drug Administration issued a drug approval number, "the drug import registration certificate" or "pharmaceutical product registration certificate" valid for a period of 5 years. The expiry of the period of validity, need to continue production or import, the applicant shall, upon expiration of the application for registration again 6 months before the validity period.

Article 128th drug registration inspection, including inspection and drug standard review. Sample inspection, refers to the drug inspection according to the inspection applicants or approved by the State Food and Drug Administration drug standard of the sample.

Article 136th the national drug standards, refers to the State Food and Drug Administration promulgated the "Pharmacopoeia of people's Republic of China", the drug registration standards and other drug standard, its content includes the quality standard, inspection method and production technology.

146th if a pharmaceutical supervisory and administrative department shall abide by the "Drug Administration Law", "administrative licensing law" and the "Drug Administration Law Implementing Regulations" provisions for drug registration deadline requirements. Said the drug registration time, the long time of drug registration acceptance, examination, approval and other work, the use of less calculation, according to the provisions of laws and regulations to suspend approval or the applicant to provide supplementary materials.

Article 154th in any of the following circumstances, the State Food and drug administration shall not grant approval: (a) different applicants submit research data, data with the same or similar, and without justifiable reasons;

Article 159th "administrative licensing law" provisions of article sixty-ninth of the situation, the State Food and drug administration according to the request of the interested party or according to its functions, can revoke the drug approval documents.

Article eighty-fourth for the importation of drugs, shall obtain the approval of overseas pharmaceutical manufacturers producing countries or regions; not approved in the production of country or region, but by the State Food and Drug Administration confirmed that the drug safety, efficacy and clinical need, can approve the import.

The "measures" drug registration management in 2007 June 18 The State Food and Drug Administration approved by the executive meeting, is hereby promulgated, shall enter into force as of October 1, 2007.

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"),