First, the noun explanation questions
1. OTC drugs. Drug retail enterprises
3. Applicants for drug registration. Drug wholesale enterprises
5. prescription drugs. drug
7. Psychotropic drugs. Supplementary application
9. The legal name of drug is 10. New drug technology transfer
Second, multiple choice questions
1. Pharmacy management was separated from medical management and started at ().
A. The system of six officials was established in the Western Zhou Dynasty in China in 1 1 century BC.
B.65438+Establishment of the Royal Pharmaceutical Society in the 7th century
C. Health legislation in the Kingdom of Sicily in Europe in the 3rd century +65438
D.65438+5th century, Genoa, Europe promulgated the Pharmacist Law.
2. In the United States, over-the-counter drugs are called ()
A.gp B. [p] C. Patent drug D.OTC.
3 drugs included in the national basic medical insurance drug list should comply with the principle of ().
Clinical necessity, safety and effectiveness, reasonable price, convenient use and market guarantee.
B clinical necessity, safety and effectiveness, reasonable price, guaranteed supply, and equal emphasis on Chinese and western medicine.
C clinical necessity, safety and effectiveness, reasonable price, guaranteed supply and convenient use.
D clinical necessity, safety and effectiveness, stable quality, guaranteed supply, and equal emphasis on Chinese and western medicine.
4. The state implements a classified management system for drugs, which divides drugs into ().
A. Special drugs and general drugs B. Traditional Chinese medicine and chemicals
C. Prescription drugs and over-the-counter drugs D. Drugs for internal and external use
5. For packaging materials and containers that are in direct contact with drugs, the following statement is wrong ()
The pharmaceutical supervisory and administrative department shall order unqualified packaging materials and containers that come into direct contact with drugs to stop using them.
B those who use unapproved packaging materials and containers that are in direct contact with drugs to produce drugs shall be treated as inferior drugs.
C due to the implementation of the product registration system, the drug supervision and administration department does not need to approve drugs.
D the drug supervision and administration department shall examine and approve drugs at the same time.
6. Drug supervision and management Each link of drug supervision refers to ()
A. Drug production, marketing, use and price link
B. drug research and development, production, marketing and use
C. drug development, production, marketing and price.
D. drug development, production, marketing, use, advertising and price.
7. Licensed pharmacist registration is valid for ()
A .2 years B .3 years C. 5 years D 10 years
The Pharmaceutical Production License is approved and issued by ().
A.SFDA B provincial drug supervision and administration department C municipal drug supervision and administration department
D. county-level drug supervision and administration departments
9. Pharmaceutical manufacturers can only produce the drug after obtaining ().
A. Pharmaceutical production license B. Pharmaceutical business license
C. Drug approval number D. New drug certificate
10 The drugs that have obtained GMP certification from the US Food and Drug Administration are ()
A. injections, radioactive drugs and biological products B. Chinese herbal pieces and Chinese herbal pieces
C. Tablets and granules D. Drugs first sold in China.
1 1. The Drug Administration Law adopted and promulgated at the 17th session of the 9th the National People's Congress Standing Committee (NPCSC) has been implemented since ().
A.200 1 February 28th B.20011February1.
C. 2002 65438+ 10 month/d.20065438+0 July 1
12. The validity period of the Registration Certificate for Imported Packaging Materials is ()
A.2 years B. 3 years C. 5 years D. 10 years
13. The management department of medical institutions is ()
A. Health administrative department B. Department in charge of pharmaceutical industry
C. Drug supervision and administration department
14. The National Adverse Drug Reaction Monitoring Center is located in ()
A. National Drug Evaluation Center of US Food and Drug Administration
B. National Drug Evaluation Center of the US Food and Drug Administration
C. National Certification Management Center of US Food and Drug Administration
D. National Pharmacopoeia Committee
15. The Measures for the Administration of Narcotic Drugs belongs to ()
A. Laws B. Administrative regulations C. Departmental regulations D. Local regulations
16. The hardware condition that medical institutions must have to ensure the quality of preparations is ().
A. Facilities, equipment and inspection instruments B. Facilities, equipment, sanitary conditions and management conditions
C. Facilities, inspection instruments and sanitary conditions D. Clean rooms, warehouses, management conditions and equipment
17. The following statement about the registered system of licensed pharmacists is correct ().
A licensed pharmacists are registered according to their academic qualifications and scope of practice.
B. Licensed pharmacists must submit continuing education transcripts for re-registration.
C if a licensed pharmacist changes his practice unit or scope in the same practice area, he needs to change his registration according to law.
D The practice scope of licensed pharmacists is drug research, production and sales.
18. It is SFDA's () internal organization that is responsible for supervising the direct contact with pharmaceutical packaging materials and containers.
A. Drug Registration Office B. Drug Safety Supervision Office
C Department of Drug Market Supervision D Department of Policy and Regulation
19. In China, the pharmaceutical institution with the largest number of pharmacists is ().
A. Drug management organizations B. Pharmaceutical organizations of medical institutions
C. Pharmaceutical Education Organization D. Pharmaceutical Affairs Management Organization
20. The person directly responsible for defrauding psychotropic drugs by taking advantage of his work has no prescription right within () years.
A.3 years B.5 years C. 10 years D. There is no such provision.
2 1. Used to identify the new process is ().
A. Spot check B evaluation inspection C arbitration inspection D national appraisal
22. Each prescription injection of narcotic drugs shall not exceed the daily dosage ().
A. 1 day B.2 days C.3 days D.4 days
23. The drug supervision and administration institution at the county level is the drug supervision and administration institution at the next higher level ()
A dispatched institution B directly affiliated institution C branch D vertical institution
24. The raw materials and auxiliary materials needed for the production of drugs must meet the requirements of ().
A health b medical c medical d production
25. The staff of drug production enterprises, drug trading enterprises and medical institutions who are in direct contact with drugs must have a health examination every ().
One month, b half a year, c one year, d two years.
26. The ADR report of drugs listed in China within five years is () ADR.
Serious B, new C, suspicious D, all suspicious.
27. Belong to the national protection of wild medicinal species is ().
A pangolin b bear gall c musk d antelope horn
The biggest injury event in the 20th century is ().
Methylsulfonamide incident, Simon incident.
C reaction stop event D PPA event
29. China's current drug expiration date is expressed as ().
A. the validity period is 2 years. B. valid until September 2003.
C. Valid until September 2003
30. This new drug refers to ()
A Drugs not yet marketed in China.
Drugs not produced in China.
C Drugs that have not been clinically tested in China.
D drugs sold by domestic manufacturers in China for the first time.
3 1. Generally, what does not need clinical research is ()
Application for registration of new chemical drugs
Apply for drug registration with national standards.
C in the supplementary application, new indications have been added to the listed drugs.
D in the supplementary application, the production process of the listed drugs has changed significantly.
32. To establish a pharmaceutical retail enterprise, the applicant shall apply to the place where the enterprise is to be established.
A provincial drug supervision and administration agency b the State Council drug supervision and administration department.
Municipal drug regulatory agencies with districts c and county drug regulatory agencies d.
According to the Drug Administration Law and its implementing regulations, () shall not be charged.
A implement drug approval inspection and its compulsory inspection B spot check inspection
C registered drugs, D issued certificates.
34. The following statement about the monitoring period of new drugs is incorrect ()
A. During the monitoring period, production and import by other enterprises shall not be approved.
B. If no new drug with monitoring period is produced within 2 years from the date of approval, SFDA may approve the application of other pharmaceutical manufacturers to produce the new drug.
The establishment of monitoring period is the need to protect public health.
D The monitoring period is 12 years, 8 years and 6 years respectively.
35 does not belong to the pharmaceutical production enterprise product production management documents is ()
A production process specification B post operation method
C standard operating procedures d batch inspection records
36. The approval number of the following chemicals during trial production is ()
A national medicine Zhunzi H20020006 B national medicine Shenzi H20020006
C National Medicine Zhunzi X20020006 D National Medicine Shenzi X20020006
37.GMP regulation, the temperature of the clean room should generally be controlled in ().
A 16℃~24℃ B 16℃~26℃
C 18℃~26℃ D 15℃~27℃
38. The following does not belong to the drug approval document is ()
A. Approval number B "Import Drug Registration Certificate"
C. Pharmaceutical product registration certificate C. Pharmaceutical production license
39. The similarities between imported drugs and new drug registration and approval procedures are ().
A. The initial acceptance subjects are the same, all of which are the State Food and Drug Administration of the United States.
B sample inspection and standard review institutions are the same, both of which are China Institute for the Control of Pharmaceutical and Biological Products.
C it must be approved by clinical research and production twice.
D. The documents issued after approval are the same.
40. For drugs with insufficient domestic supply, the authority that has the right to restrict or prohibit the export is ().
A. U.S. Food and Drug Administrationb Department of Health
C State General Administration of Customs D the State Council
4 1. The species of wild medicinal materials not under national first-class protection is ()
A leopard bone b musk c antelope horn d velvet antler (sika deer)
42. The Drug Administration Law passed and promulgated at the 17th session of the Ninth the NPC Standing Committee has been implemented since ().
A.200 1 February 28th B.20011February1.
C. 2002 65438+ 10 month/d.20065438+0 July 1
43. Does not belong to the pharmaceutical production enterprise product quality management documents is ()
Batch production record
B batch inspection records
Study on quality stability of C products
Drug application and approval documents
44. The validity period of the Registration Certificate for Imported Packaging Materials is ().
A.2 years B. 3 years C. 5 years D. 10 years
45. In the United States, over-the-counter drugs are called () D.
Answer. GSL B. GP C. Patented drug D OTC
46. The drug supervision and administration institution at the county level is the drug supervision and administration institution at the next higher level ()
A dispatched institution B directly affiliated institution C branch D vertical institution
47. China's report on adverse drug reactions of drugs listed for more than five years is () adverse reactions.
One is serious, one is rare, and the other is suspicious.
Adverse reactions caused by suspected overdose.
48. The validity of a patent for pharmaceutical invention is counted from ().
A application date b announcement date c approval date d completion date
49. The following belong to the approval number of imported repackaged drugs ()
National medicine Zhunzi X20020006
National medicine Zhunzi H20020006
National medicine Zhunzi J20020006
Chinese medicine dictionary J20020006
50. Class A OTC drugs must be printed with a special logo ().
A. white characters on green background b white characters on red background c white characters on black background d white characters on blue background
5 1. The organ that has the right to restrict or prohibit the export of drugs with insufficient domestic supply is ().
A. U.S. Food and Drug Administrationb Department of Health
C State General Administration of Customs D the State Council
52. The compilation of China Pharmacopoeia (2000 edition) is based on the guiding ideology of ().
A. catch up with the national conditions; Highlight characteristics, based on improvement.
C. Based on the national conditions, the combination of advanced nature and characteristics
53. The United States food and drug administration is responsible for drug GMP certification is ().
A. injections, radioactive drugs and biological products B. Chinese herbal pieces and Chinese herbal pieces
C. Tablets and granules D. Drugs first sold in China.
54. The Drug Administration Law stipulates that () is one of the necessary conditions for the establishment of a drug trading enterprise.
Having pharmaceutical technicians qualified according to law.
B. the chief pharmacist who has obtained the practicing qualification according to law
(3) Pharmacists and traditional Chinese medicine pharmacists who have obtained professional qualifications according to law.
D. Qualified pharmacists are responsible according to law.
55. The Pharmaceutical Production License is approved and issued by ().
A.SFDA B provincial drug supervision and administration department
Drug supervision and administration department of C city and drug supervision and administration department of D county.
56. About prescription drug advertising regulations, which statement is correct ()
A It can be introduced in medical and pharmaceutical journals designated by the health administrative department of the State Council.
B it can be introduced in medical and pharmaceutical journals designated by the drug supervision and administration department of the State Council.
It can be introduced in medical and pharmaceutical journals designated by the Ministry of Health and the US Food and Drug Administration.
Do not publish advertisements in various media.
57. The preparation of pharmaceutical preparations by medical institutions shall be subject to the local () examination and approval, and a Pharmaceutical Preparation License for Medical Institutions shall be issued after approval. No preparation may be prepared without the Pharmaceutical Preparation License of Medical Institution. ( )
The drug supervision and administration department of the provincial government; Health administrative department of the provincial government
State drug supervision and administration department; Provincial government drug supervision and administration department
Health administrative departments of provincial governments; Health administrative department of the provincial government
D. Health administrative departments of provincial governments; Provincial government drug supervision and administration department
58. Investigate the efficacy and adverse reactions of drugs under the condition of extensive use ().
Pre-clinical study B I clinical trial
C phase Ⅱ clinical trial D phase Ⅳ clinical trial
59. The inner packaging label of drugs must be marked with ().
A drug name, specification, production batch number b indications, usage and dosage
C Usage and dosage, indications, drug name D production batch number, adverse reactions, contraindications
60. New drug technology transfer requirements, accept the new drug technology transfer production enterprises must obtain ()
A. new drug certificate
Pharmaceutical production license
C. new drug certificate and drug production license
Drug production license and GMP certification certificate
Third, question and answer.
1. How long is the protection period of the first-class protected varieties of traditional Chinese medicine? What conditions do Chinese medicine varieties applying for first-class protection need to meet?
2. What drugs are classified as inferior drugs in China's Drug Administration Law?
3. Medicine is a special commodity. What is its particularity?
4. Which drugs are not allowed to advertise?
Article 48 of the Drug Administration Law stipulates that "the production and sale of counterfeit drugs are prohibited". What does "fake medicine" mean here?
6. What is the role of drug supervision and management?
7 When applying for new drugs, which drugs need quick approval?
8. What are the requirements for applying for the second-class protected varieties of traditional Chinese medicine? How long is the protection period?
Reference answer to pharmaceutical affairs management
First, the noun explanation questions
1. Over-the-counter drugs: published by SFDA, consumers can judge, buy and use drugs by themselves, without the prescription of medical practitioners and assistant medical practitioners.
2. Retail enterprises refer to pharmaceutical trading enterprises that directly sell purchased drugs to consumers.
3. Drug registration applicant: refers to the institution that applies for drug registration and bears corresponding legal responsibilities, and holds the drug approval certificate after the application is approved.
4. Pharmaceutical wholesale enterprises refer to pharmaceutical trading enterprises that sell purchased drugs to pharmaceutical production enterprises, pharmaceutical trading enterprises and medical institutions.
5. Prescription drugs: drugs that can only be purchased, prepared and used with the prescriptions of medical practitioners and assistant medical practitioners.
6. Narcotic drugs refer to drugs that are prone to physical dependence and addiction after continuous use.
7. Psychotropic drugs: refers to drugs that directly act on the central nervous system, make it excited or inhibited, and continue to use drugs that can produce dependence.
8. Supplementary application: refers to the registration application for changing, adding or canceling the original approved items or contents after the application for new drugs, drugs with national standards or imported drugs is approved.
9. The names of drugs listed in the national drug standards are also called generic names.
10. It refers to the act that the holder of a new drug certificate transfers the production technology of a new drug to a pharmaceutical production enterprise, and the pharmaceutical production enterprise applies for the production of the new drug.
Second, multiple choice questions
1-5 CDACC 6- 10 DBBCA 1 1- 15 BBABB 16-20 CCA BD 2 1-25 BBACC
26-30 DDCCA 3 1-35 bcbdd 36-40 bcccd 4 1-45 BBABD 46-50 AAACB
5 1-55DBAAB 56-60 CDDAD
Third, question and answer.
1, a: 30/20/ 10 years respectively.
Traditional Chinese medicine varieties that meet one of the following conditions may apply for first-class protection
It has a special therapeutic effect on specific diseases.
Second, it is equivalent to the artificial products that protect wild medicinal species at the national level.
Used for preventing and treating special diseases.
2. Answer: If the content of drug ingredients does not meet the national drug standards, it is an inferior drug.
Drugs under any of the following circumstances shall be punished as inferior drugs.
Failing to indicate the validity period or changing the validity period
Failing to indicate or change the production batch number
3. beyond the validity period.
Packaging materials and containers in direct contact with drugs are not allowed.
Colorants, preservatives, spices, correctants and auxiliary materials are added without authorization.
Others do not meet the requirements of drug standards.
3, medicine is a special commodity, its particularity is reflected in?
A: One is life relevance, and the other is high quality.
Three fairs * * * welfare four colleges
Five-function duality and six-time limit
Seven varieties with limited yield
4. Answer: 1. Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drug rehabilitation drugs and special management drugs recognized by the national medical device management department.
Drugs whose production, sale and use have been explicitly stopped or prohibited by the State Pharmaceutical Products Administration or the provincial pharmaceutical supervisory and administrative departments.
Preparations prepared by medical institutions
Drugs approved for trial production by the State Administration of Pharmaceutical Products.
5. A: In any of the following circumstances, it belongs to counterfeit drugs.
1. The ingredients contained in this drug do not meet the requirements of national drug standards.
2. passing off non-drugs as drugs or passing off other drugs as drugs.
Drugs under any of the following circumstances shall be treated as counterfeit drugs.
Drugs prohibited by the drug supervision and administration department of the State Council.
Production and import that must be approved according to this law without approval, or sales that must be inspected without inspection according to this law.
Three deterioration, four pollution.
(five) the use of raw materials that should have obtained the approval number in accordance with the provisions of this law, but have not obtained the approval number.
6 indications or functional indications beyond the prescribed scope.
6. A: First, ensure the quality of drugs.
Promote the research and development of new drugs to ensure that the research and development of new drugs is more effective and safer.
Third, improve the competitiveness of the pharmaceutical industry, quality is the basis of enterprise survival competition, but enterprises often ignore it, and the government strengthens supervision to ensure quality, thus improving competitiveness.
Standardize the drug market and ensure the supply of drugs.
To provide guarantee for rational drug use and prevent drug abuse.
7. Answer: 1. New Chinese medicine II. Chemicals that have not been approved for listing at home and abroad.
Three. Anti-AIDS drugs, etc. Four. A new drug for diseases that cannot be effectively treated.
8. A: The protection period is 7 years.
Meet one of the following conditions, you can apply for two.
Varieties that meet the first-class protection conditions or have been released from the first-class protection.
(2) It has obvious curative effect on specific diseases.
Effective substances and special preparations extracted from natural medicines