Knowledge summary of drug management

Do you know how to manage drugs? Do you know how to manage drugs? The following is the drug management knowledge I have brought to you, welcome to read.

1. New drug development and approval

(1) To develop new drugs, the development methods, quality indicators, and Clinical trials can only be conducted after the pharmacological and toxicological test results and other relevant data and samples have been approved by the drug regulatory department of the State Council.

(2) The qualification accreditation method for 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.

(3) 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.

2. Approval for the production of new drugs and existing national standard drugs: must be approved by the drug regulatory department of the State Council and issued with a drug approval number (except for the production of Chinese herbal medicines and Chinese herbal pieces that are not subject to approval number management) ).

The catalog of Chinese medicinal materials and Chinese medicinal 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.

3. The agency that formulates and revise national drug standards

(1) Drugs must comply with: national drug standards.

(2) The formulation and revision of national drug standards: the National Pharmacopoeia Commission is responsible.

(3) National drug standards include: "Chinese Pharmacopoeia" and other drug standards promulgated by the State Food and Drug Administration.

4. Drug purchasing channels

Drug manufacturing enterprises, drug operating enterprises, and medical institutions must purchase drugs from enterprises with drug production and operation qualifications (those that do not implement approval number management Except for Chinese medicinal materials).

Note: Traditional Chinese medicine pieces that are not subject to approval number management must also be purchased from qualified companies.

5. Drugs under special management

Narcotic drugs, psychotropic drugs, toxic drugs for medical use, and radioactive drugs are subject to special management, and the management regulations are formulated by the State Council.

Note: Detoxification drugs do not fall within the scope of specially managed drugs. However, narcotic detoxification drugs are managed as narcotic drugs.

6. Import and export drug management

(1) Approval authority: The State Food and Drug Administration issues the "Import Drug Registration Certificate".

(2) The imported drugs that do not need to apply for a "Registration Certificate" are: small quantities of drugs imported for clinical urgent need by medical units or for personal use (import procedures should be handled in accordance with relevant national regulations).

(3) Procedures for importing drugs: They must be imported from a port that allows drug import, and the enterprise that imports drugs must register with the drug regulatory department where the port is located. The customs will release the goods based on the "Imported Drug Customs Clearance Form" issued by the drug supervision and administration department. Without the "Imported Drugs Customs Clearance Form", the customs shall not release the goods.

The drug regulatory department where the port is located should notify the drug inspection agency to conduct random inspections of imported drugs and collect inspection fees.

The ports that allow imports shall be proposed by the Drug Supervision and Administration Department of the State Council in conjunction with the General Administration of Customs and submitted to the State Council for approval.

(4) It is prohibited to import drugs that have inaccurate efficacy, serious adverse reactions or other reasons that endanger human health.

(5) The State Council has the power to restrict or prohibit the export of drugs that are in insufficient domestic supply.

(6) Import and export of narcotic drugs and psychotropic drugs within the scope of national regulations: You must hold an "Import Permit" and "Export Permit" issued by the Drug Supervision and Administration Department of the State Council.

Note: Imported narcotic drugs and psychotropic drugs within the scope of national regulations require both a "Registration Certificate" and a "Permit".

7. Organization and processing of drug evaluation and re-evaluation

The drug regulatory department of the State Council organizes pharmaceutical, medical and other technical personnel to review new drugs and review those that have been approved for production. Drugs are re-evaluated.

The drug regulatory department of the State Council shall organize investigations into drugs that have been approved for production or import; for drugs with uncertain efficacy, severe adverse reactions, or other reasons that endanger human health, the approval number or imported drugs shall be revoked Certificate of Registration.

Drugs whose approval number or imported drug registration certificate has been revoked shall not be produced or imported, sold or used; drugs that have been produced or imported: shall be destroyed or disposed of under the supervision of the local drug regulatory department.

8. Drug reserve management

The state implements a drug reserve system.

9. Identification of counterfeit and inferior drugs and situations in which they are treated as counterfeit and inferior drugs

Counterfeit drugs: (1) The ingredients contained in the drug do not comply with the ingredients specified in the national drug standards ;

(2) Passing off non-drugs as drugs or other drugs as such drugs.

If any of the following circumstances occurs, it will be treated as a counterfeit drug

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

(2) In accordance with this article Produced or imported without approval if the law requires approval, or sold without inspection if the law requires inspection;

(3) Deterioration;

(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 functions are beyond the prescribed scope.

Inferior drugs: The content of drug ingredients does not meet the national drug standards.

If any of the following circumstances occurs, it will be treated as an inferior drug

(1) Failure to indicate the validity period or changing the validity period;

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

(3) Expiration date exceeded;

(4) Packaging materials and containers in direct contact with drugs are not approved;

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

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

10. Drug name regulations

(1) The names of drugs listed in national drug standards are the common names of drugs.

(2) If it has been used as a common name of a drug, the name shall not be used as a drug trademark.

11. Health examination

(1) Workers in drug manufacturing enterprises, drug operating enterprises and medical institutions who are in direct contact with drugs must undergo health examinations every year.

(2) Those suffering from infectious diseases or other diseases that may contaminate medicines are not allowed to engage in work with direct contact with medicines. ;