Chapter 5 Drug Management

Article 29 When developing new drugs, the development methods, quality indicators, pharmacological and toxicological tests must be truthfully submitted in accordance with the regulations of the drug regulatory department of the State Council. Clinical trials can only be conducted after the results and other relevant data and samples have been approved by the drug regulatory department of the State Council. The methods for determining the qualifications of drug clinical trial institutions shall be jointly formulated by the drug regulatory department of the State Council and the health administration department of the State Council. New drugs that have completed clinical trials and passed review and approval shall be approved by the drug regulatory department of the State Council and issued a new drug certificate.

Article 30 Non-clinical drug safety evaluation research institutions and clinical trial institutions must implement drug non-clinical research quality management standards and drug clinical trial quality management standards respectively. The Quality Management Standards for Drug Non-clinical Research and the Quality Management Standards for Drug Clinical Trials shall be formulated by the departments designated by the State Council.

Article 31 The production of new drugs or drugs with national standards must be approved by the drug regulatory department of the State Council and issued with a drug approval number; however, the production of traditional Chinese medicines that do not implement approval number management Except for raw materials and traditional Chinese medicine pieces. The catalog of Chinese herbal medicines and Chinese herbal pieces subject to approval number management shall be formulated by the drug regulatory department of the State Council in conjunction with the traditional Chinese medicine management department of the State Council. Drug manufacturers can only produce the drug after obtaining the drug approval number.

Article 32 Drugs must comply with national drug standards. Traditional Chinese medicine preparations shall be made in accordance with the provisions of paragraph 2 of Article 10 of this Law. The "Pharmacopoeia of the People's Republic of China" and the drug standards promulgated by the drug regulatory department of the State Council are national drug standards. The drug regulatory department of the State Council organizes a Pharmacopoeia Committee, which is responsible for the formulation and revision of national drug standards. The drug inspection agency of the drug regulatory department of the State Council is responsible for the calibration of national drug standards and reference materials.

Article 33 The drug regulatory department of the State Council shall organize pharmaceutical, medical and other technical personnel to review new drugs and re-evaluate drugs that have been approved for production.

Article 34 Drug manufacturing enterprises, drug operating enterprises, and medical institutions must purchase drugs from enterprises with drug production and operation qualifications; however, the purchase of Chinese herbal medicines that are not subject to approval number management is excluded. .

Article 35: The state implements special management on narcotic drugs, psychotropic drugs, toxic drugs for medical use, and radioactive drugs. Management measures shall be formulated by the State Council.

Article 36 The state implements a system for the protection of traditional Chinese medicine varieties. Specific measures shall be formulated by the State Council.

Article 37 The state implements a classified management system for prescription drugs and over-the-counter drugs. Specific measures shall be formulated by the State Council.

Article 38 It is prohibited to import medicines with uncertain efficacy, serious adverse reactions or other reasons that endanger human health.

Article 39: The import of drugs must be reviewed by the drug regulatory department of the State Council. Only after the review is confirmed to be in compliance with quality standards, safe and effective, can the import be approved and an imported drug registration certificate be issued. A small amount of imported drugs that are urgently needed for clinical use by medical units or for personal use must go through import procedures in accordance with relevant national regulations.

Article 40 Drugs must be imported from ports that allow the import of drugs, and the enterprises that import drugs must register with the drug regulatory department where the port is located. The customs will release the goods based on the "Imported Drug List" issued by the drug supervision and administration department. If there is no "Imported Drug List", the customs shall not release it. The drug supervision and administration department where the port is located shall notify the drug inspection agency to conduct random inspections and inspections of imported drugs in accordance with the provisions of the drug supervision and administration department of the State Council, and collect inspection fees in accordance with the provisions of paragraph 2 of Article 41 of this Law. Ports that allow the import of drugs shall be proposed by the drug regulatory department of the State Council in conjunction with the General Administration of Customs and submitted to the State Council for approval.

Article 41 The drug regulatory department of the State Council shall designate drug inspection agencies to inspect the following drugs before they are sold or when they are imported; those that fail the inspection shall not be sold or imported:

(1) Biological products stipulated by the drug regulatory department of the State Council;

(2) Drugs sold in China for the first time;

(3) Other drugs stipulated by the State Council. The inspection fee items and charging standards for the drugs listed in the preceding paragraph shall be determined and announced by the financial department of the State Council in conjunction with the price department of the State Council. The methods for collecting inspection fees shall be formulated by the financial department of the State Council in conjunction with the drug regulatory department of the State Council.

Article 42 The drug regulatory department of the State Council shall organize investigations into drugs that have been approved for production or import; and shall revoke approval for drugs that have inaccurate efficacy, severe adverse reactions, or other reasons that endanger human health. Document number or imported drug registration certificate. Drugs whose approval number or imported drug registration certificate has been revoked shall not be produced or imported, sold or used; if they have been produced or imported, they shall be destroyed or disposed of under the supervision of the local drug regulatory department.

Article 43 The state implements a drug reserve system. When major disasters, epidemics and other emergencies occur in the country, departments specified by the State Council may urgently mobilize corporate drugs.

Article 44: The State Council has the power to restrict or prohibit the export of drugs that are in insufficient domestic supply.

Article 45 To import or export narcotic drugs and psychotropic drugs within the scope of national regulations, you must hold an "Import Permit" and "Export Permit" issued by the drug regulatory department of the State Council.

Article 46: Newly discovered medicinal materials and medicinal materials introduced from abroad can only be sold after being reviewed and approved by the drug regulatory department of the State Council.

Article 47: The management measures for regional folk customary medicinal materials shall be formulated by the drug regulatory department of the State Council in conjunction with the traditional Chinese medicine management department of the State Council.

Article 48 It is prohibited to produce (including preparation, the same below) and sell counterfeit drugs. If any of the following circumstances occurs, it is considered a counterfeit drug:

(1) The ingredients contained in the drug are inconsistent with the ingredients specified in the national drug standards;

(2) Non-drugs are passed off as drugs Or passing off other medicines as this kind of medicine. Drugs that fall under any of the following circumstances shall be treated as counterfeit drugs:

(1) The use is prohibited by the drug regulatory department of the State Council;

(2) The drug must be approved in accordance with this law but has not been approved Products that have been approved for production or import, or are subject to inspection in accordance with this Law but are sold without inspection;

(3) Deteriorated;

(4) Contaminated; (5) Produced using raw materials that must obtain an approval number in accordance with this Law but have not obtained an approval number;

(6) The indicated indications or functional indications exceed the prescribed scope.

Article 49 The production and sale of inferior drugs is prohibited. If the content of drug ingredients does not meet the national drug standards, it is considered an inferior drug. Drugs that fall under any of the following circumstances will be treated as inferior drugs:

(1) Failure to indicate the validity period or change of the validity period;

(2) Failure to indicate or change the production batch number;

(3) The validity period has expired;

(4) The packaging materials and containers in direct contact with the drug are not approved;

(5) Adding coloring without authorization Agents, preservatives, spices, flavorings and auxiliary materials;

(6) Others that do not comply with drug standards.

Article 50 The names of drugs included in the national drug standards shall be the common names of the drugs. If it is already a common name of a drug, the name shall not be used as a drug trademark.

Article 51: Staff members of pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises and medical institutions who are in direct contact with pharmaceuticals must undergo health examinations every year. Those suffering from infectious diseases or other diseases that may contaminate medicines are not allowed to engage in work with direct contact with medicines.