(a) industry management system
1, industry authorities
The competent departments of the pharmaceutical industry for the state and local food and drug administration.
2, industry regulatory system
The daily management of drug production enterprises must follow the relevant policies and regulations of the national pharmaceutical industry management:
(1) drug production license system,
In our country started pharmaceutical producing enterprises, must be approved by the company is located in province, autonomous region, municipality directly under the central government of the people's Government of the pharmaceutical supervisory and administrative departments and sent to the pharmaceutical production license, by the pharmaceutical production license to the administrative department for Industry and Commerce for registration. The "drug production license" shall indicate the validity and scope of production and re - examine the certification. No "drug production license" may not produce drugs.
(2) drug production quality management rules
Drug production enterprises must be in accordance with the State Council, the drug regulatory authorities to develop the "drug production quality management norms," the organization of production. Drug regulatory authorities in accordance with the provisions of the drug production enterprises are in compliance with the "drug production quality management standards" requirements for certification; certification of qualified, issued a certificate (drug GMP certificate). Only holding a certificate of certification of enterprises can be carried out within the scope of the certification of drug production.
(3) drug clinical trial system
Drug production enterprises to apply for new drug registration, generic drug application and supplementary application, according to the relevant provisions of clinical trials. Clinical trials for I, II, III, IV, and clinical trials of a drug must be approved by the drug regulatory agency of the State Council, issued a "drug clinical trial approval", and must execute the criterions for the quality control of clinical trials of drugs. Clinical trials of drugs should be in line with the "drug production quality management norms," the preparation of the workshop. Preparation process should strictly implement the requirements of the quality control of pharmaceutical production.
(4) a new drug certificate and drug production licenses
Completion of clinical trials and approval of new drugs, the State Council approved by the drug regulatory authority, issued a new drug certificate. Changes in dosage form but does not change the route of administration, as well as the increase in new indications for approval after the approval is not issued to the new drug certificate; targeted drugs, slow release, controlled release formulations, such as special formulations except. Production of a new drug or has been the national standard of drugs shall be approved by the drug regulatory agency of the State Council, and sent to drug production licenses. Drug production enterprises in the acquisition of drug production licenses, can produce the drug.
(5) drug standards
The national drug standard is refers to the country in order to ensure the quality of drugs developed on quality indicators, inspection methods and the production technology and other technical requirements, including the Pharmacopoeia of the people's Republic of China, the drug registration standards and other drug standards. The Pharmacopoeia Commission of the drug regulatory department under the State Council shall be responsible for the formulation and revision of the national drug standards.
(6) drug pricing
Countries included in the catalogue of national basic medical insurance, pharmaceutical drugs and included in the national development and Reform Commission drug pricing catalogue of narcotic drugs, a class of psychoactive drugs and other government guidance prices, to included in the national development and Reform Commission drug pricing catalogue contraceptives, planned immunity drug, the implementation of government pricing form. Government guidance price for the highest retail price, the operator can float downward price, the range is not limited.
(7) the prescription and non prescription drugs classification management system
The classification management system of prescription and non prescription drugs in our country. Prescription and non prescription drugs classification management is the international drug management, through the strengthening of the supervision and management of prescription and non prescription drugs can standardize the drug production, management behavior, guide public scientific and rational drug use, reduce the occurrence of drug abuse and drug adverse reactions, protect drug safety for the people.
(8) new drug monitoring period and generic drugs
The monitoring period of new drug establishment in China is not more than 5 years. During the monitoring period of new drugs, the State Food and drug administration does not approve other companies to produce, change dosage forms and imports. New drugs into day monitoring period, State Food and drug administration has approved other applicants of drug clinical trials, can in accordance with the drug registration application, examination and approval procedures to handle the application and in compliance with the provisions, the State Food and Drug Administration approved the production or import of the new drug, and the environment of medicine production enterprises in the production of the new drug together with monitoring. The date of the new drug into the monitoring period, no longer accept other applicants with a variety of applications for registration. Has been accepted but not yet approved for clinical trials of drugs and other applicants with a variety of applications to be returned. After the expiration of the new drug monitoring, the applicant may apply for a generic drug application or import drug application.
(9) drug import system
The imported drugs shall be state food and drug administration organization review, the review confirmed that meet to be Chinese standards of quality, safety and effectiveness can be approved to be imported and issued a drug registration certificate. Among them, foreign enterprises in the production of drugs shall be issued to the drug import registration certificate, Hong Kong, Macao and Taiwan enterprises in the production of drugs shall be issued to the pharmaceutical product registration certificate, the certificate of registration of drug import. Application for imported drugs repackaged drugs should have made the drug import registration certificate or registration certificate of pharmaceutical products drug, be subject to the examination and approval of the State Food and drug administration, in line with the relevant provisions of issued the supplementary drug application approval document "and a drug approval number.