I. Nomenclature Questions
1. over-the-counter drugs 2. drug retailers
3. applicants for drug registration 4. drug wholesalers
5. prescription drugs 6. narcotic drugs
7. psychotropic drugs 8. supplemental applications
9. legal names of medicines 10. transfer of technology of new medicines
Single-choice questions
II. p>1. The separation of pharmacy management from pharmaceutical management began in the ( )
A. The establishment of the Six Officials system in the Western Zhou Dynasty of China in the 11th century B.C.
B. The establishment of the Royal Pharmaceutical Society of Great Britain in the 17th century
C. The health legislation of the Kingdom of Sicily in Europe in the 13th century
D. The enactment of the Pharmacist's Law by the city of Genoa in Europe in the 15th century
2.In the United States, over-the-counter drugs are called ( )
A. GP B. [P] C. Proprietary Drugs D. OTC
3.Drugs that are included in the National Basic Medical Insurance Drug List should be in accordance with the principle of ( ).
A. Clinically necessary, safe and effective, reasonably priced, easy to use, and the market can guarantee supply.
B. Clinically necessary, safe and effective, reasonably priced, supply guaranteed, and both Chinese and Western medicines emphasized.
C. Clinically necessary, safe and effective, reasonably priced, supply guaranteed, easy to use.
D. Clinical necessity, safety and efficacy, stable quality, guaranteed supply, and equal emphasis on Chinese and Western medicines.
4. The state implements a classification and management system for medicines, dividing them into ( )
A. special and general medicines B. Chinese medicines and chemicals
C. prescription and over-the-counter medicines D. medicines for internal use and medicines for external use
5. For packaging materials and containers that come into direct contact with medicines, the following is incorrectly stated ( )
A. The packaging materials and containers that are not qualified for direct contact with medicines should not be used in a way that is not suitable for the purpose. Qualified packaging materials and containers in direct contact with medicines, the drug supervision and management department ordered to stop using
B. The use of unapproved packaging materials and containers in direct contact with medicines to produce drugs, according to the punishment of substandard medicines
C. Because of the implementation of the product registration system, drug supervision and management department in the approval of medicines do not need to be re-approved
D. By the drug supervision and management department in the approval of medicines together with the approval of < / p>
D. In the approval of drugs together with the approval
6. Drug supervision and management of the various aspects of drug supervision and management refers to ( )
A. drug production, operation, use, price of the link
B. drug development, production, operation, use of the link
C. drug development, production, operation, price of the link
D. drug development, production, use, advertising, price of the link
D. drug development, production, operation, use, advertisement, price of the link, operation, use, advertising, price of the link
7. licensed pharmacist registration is valid for ( )
A .2 years B .3 years C. 5 years D 10 years
8 "Drug Manufacturing License" is approved and issued by ( )
A. SFDA B Provincial Drug Supervision and Administration C Municipal Drug Supervision and Administration Department
D County level D county-level drug supervision and management department
9 A drug manufacturer can produce a drug only after obtaining ( ).
A. Drug Manufacturing License B. Drug Business License
C. Drug Approval Number D. New Drug Certificate
10 Drugs for which the State Food and Drug Administration (SFDA) is responsible for GMP certification are ( )
A. Injections, Radioactive Drugs, and Biological Products B. Traditional Chinese Medicines (TCM) Drinking Tablets, and Traditional Chinese Medicines (TCM)
C. Tablets and Granules D. Drugs that are sold in China for the first time. Drugs sold in China for the first time．
11. The Drug Administration Law, adopted and promulgated by the 17th meeting of the Standing Committee of the Ninth National People's Congress, has been in force since ( )
A. February 28, 2001 B. December 1, 2001
C. January 1, 2002 D. July 1, 2001
12. The Certificate of Registration of Imported Pharmaceutical Packaging Material The validity of the "Certificate of Registration of Imported Pharmaceutical Packaging Materials" is ( )
A. 2 years B. 3 years C. 5 years D. 10 years
13.The competent authority for the administration of health care institutions is ( )
A. Health administration B. Pharmaceutical industry authorities
C. Drug supervision and management D. Industry and commerce administration
14.The National Center for Adverse Reaction Monitoring is located in ( )
14. The National Adverse Reaction Monitoring Center is located in ( )
A. Center for Drug Evaluation of the State Food and Drug Administration (CDEA)
B. Center for Drug Evaluation of the State Food and Drug Administration (CDEA)
C. Center for Accreditation of the State Food and Drug Administration (CACDA)
D. State Pharmacopoeia Commission (CPC)
15.
A. Laws B. Administrative Regulations C. Departmental Regulations D. Local Regulations
16. The hardware conditions that medical institutions must have to ensure the quality of preparation are ( )
A. facilities, equipment, testing instruments B. facilities, equipment, sanitary conditions, management conditions
C. facilities, testing instruments, hygienic conditions D. clean rooms, warehouses, Management conditions, equipment
17. The following statements about the registration system of licensed pharmacists, which is correct ( )
A. licensed pharmacists by education, scope of practice registration
B. licensed pharmacists re-registration must be submitted to the licensed pharmacist continuing education transcripts
C. licensed pharmacists to change the practice unit or scope of practice in the same practice area, the need for change in accordance with law Registration
D. The scope of practice of licensed pharmacists for drug development, production, operation
18. responsible for direct contact with the regulation of pharmaceutical packaging materials and containers is the SFDA internal institutions ( )
A. Drug Registration Division B Drug Safety Supervision Division
C Drug Market Supervision Division D Policy and Regulations Division
19 . In our country, the pharmacist the most pharmacist organization is ( )
A. drug business organization B. medical institutions pharmacy organization
C. pharmacy education organization D. drug management administrative organization
20 . use the convenience of work, for their own prescription, fraudulent psychotropic drugs directly responsible for ( ) years do not have the right to prescribe.
A.3 years B.5 years C.10 years D.No such provision
21. used to identify the new process is ( )
A. Sampling test B Evaluative test C Arbitration test D National identification
22. Narcotic drugs shall not be injected more than ( ) daily dosage for each prescription
A.1 days B.2 days C.3 days D.4 days
23. county-level drug supervision and management agencies for the upper level of drug supervision and management agencies ( )
A sent agencies B directly under the agency C branch agencies D vertical agencies
24. raw materials and auxiliary materials required for the production of drugs must meet the requirements of ( ).
A sanitary B medical C medicinal D production
25.Drug manufacturers, drug companies and medical institutions directly in contact with the staff of drugs, must be every ( ) health checks.
A month B half a year C year D two years
26.China's adverse drug reactions on the market within five years of the drugs, adverse drug reaction reporting scope is ( ) adverse reactions
A serious B new C suspicious D all suspicious
27.belonging to the national level of protection of the wild species of medicinal herbs are ( )
A pangolin B bear gall bladder C musk D antelope horn<
28. The biggest drug incident in the twentieth century is ( ）
A Sulfonamide chemicals incident B Smon incident
C Reaction stop incident D .PPA incident
29. China's current drug expiration date is expressed as ( )
A. valid for 2 years B. valid until September 2003
C. valid until D. expiration date until September 2003
30. New drugs are ( )
A drugs that have not been marketed and sold in China
B drugs that have not been produced in China
C drugs that have not been subjected to clinical trials in China
D drugs that have been marketed for the first time by a domestic manufacturer in China
31. Clinical studies are generally not required for ( )
A Application for Registration of New Chemical Drugs
B Application for Registration of Drugs for which National Standards Already Exist
C Supplementary Application for Addition of New Indications to Listed Drugs
D Supplementary Application for Significant Changes to Listed Drugs' Manufacturing Processes, etc.
32. Enterprise, the applicant shall apply to the proposed location of the enterprise ( )
A Provincial Drug Administration B State Council Drug Administration
C Municipal drug supervision and management agencies D county-level drug supervision and management agencies
33 According to the "Drug Administration Law" and its implementing regulations, shall not be charged a fee of ( )
A Implementation of the drug approval test and its mandatory test B Random Inspection test
C Registration of drugs D Issuance of certificates
34 The following for the monitoring period of the new drug is incorrectly stated ( )
A in the monitoring period, shall not be approved for other enterprises to produce and import
B set up a monitoring period of the new drug is not produced from the date of approval of the two years, SFDA SFDA may approve the application of other drug manufacturers to produce the new drug
C The establishment of the monitoring period is required for the protection of public health
D The monitoring period is 12 years, 8 years, 6 years
35 are not part of the production management documents of drug manufacturers ( )
A Production process regulations B post operation method
C Standard operating procedures D Batch inspection records Operating procedures D batch inspection records
36. The following trial period of chemical approval number is ( )
A State Drug Permit H20020006 B State Drug Test H20020006
C State Drug Permit X20020006 D State Drug Test X20020006
37. GMP provides that the temperature of the clean room Generally should be controlled in ( )
A 16 ℃ ~ 24 ℃ B 16 ℃ ~ 26 ℃
C 18 ℃ ~ 26 ℃ D 15 ℃ ~ 27 ℃
38. The following does not belong to the proof of approval of the drug is ( )
A. Approval No. B "Imported Drugs Registration Certificate"
C "Pharmaceutical Product Registration Certificate" C. "Drug Manufacturing License"
39. Imported drug registration approval and new drug registration approval process is the same ( )
A. Initial acceptance of the same main body, are the State Food and Drug Administration
B sample testing and standards review of the same institutions, are the China Pharmaceutical and Biological Products Inspection Institute
C. Are subject to clinical research and production of two approval<
D. The same certification documents are issued after approval
40.The authority that has the right to restrict or prohibit the export of medicines that are in short supply domestically is the ( )
A. State Food and Drug Administration B. Ministry of Health
C. State General Administration of Customs D. State Council
41.The species of wild medicinal herbs that do not belong to the national level of protection are the ( )
A Leopard Bone B Musk C Antelope Horn D Deer Antler (Sika Deer)
42. The Drug Administration Law, adopted and promulgated by the 17th meeting of the Standing Committee of the Ninth National People's Congress, came into force on ( )
A. February 28, 2001 B. December 1, 2001
C. January 1, 2002 D. July 1, 2001
43.
43. Not belong to the drug manufacturer product quality management documents are ( ）
A batch production records
B batch inspection records
C product quality stability inspection
D the application and approval of the drug documents
44. "Imported pharmaceutical packaging materials, Certificate of Registration" is valid for ( ）
A. 2 years B. 3 years C. 5 years
A. 2 years Years B. 3 Years C. 5 Years D .10 Years
45.In the United States, over-the-counter medicines are called ( ) D
A . GSL B . GP C .Proprietary Drugs D OTC
46.County-level drug supervision and management agencies are ( )
A Dispatching agencies B Directly subordinate agencies C Branching agencies D Vertical agencies
47.China's adverse drug reaction reporting scope for drugs that have been on the market for more than five years is ( )Adverse reactions
A Serious, rare and new B All suspicious
C Suspicious D Adverse reactions arising from overdose of medicines
48. The validity period of the invention patents of medicines is calculated from ()（）.
A Date of filing B Date of announcement C Date of approval D Date of completion
49. The following are the approval numbers of imported sub-packaged medicines (（）
) A State Drug Permit X20020006
B State Drug Permit H20020006
C State Drug Permit J20020006
D State Drug Test J20020006
50. Class A non-prescription drugs are required to be printed with a special logo is ( )
A. green background white letter B red background white letter C black background white letter D white letters on a blue background
51. The authority that has the right to restrict or prohibit the export of medicines that are in short supply domestically is the ( )
A. State Food and Drug Administration B Ministry of Health
C State General Administration of Customs D State Council
52. The compilation of Chinese Pharmacopoeia 2000 edition, a guiding ideology ( )
A. Catch-up and national conditions B highlight the characteristics, based on the improvement
C. advanced and characteristics of the combination D based on national conditions
53. by the State Food and Drug Administration is responsible for the GMP certification of medicines are ( )
A. injections, radiopharmaceuticals, biologics B. traditional Chinese medicines, herbal medicine
C. tablets, granules D. first time in China to sell The medicines...
54. The Drug Administration Law stipulates that one of the conditions that must be met in order to start a drug business is ( )
A. pharmacy technicians who have been qualified in accordance with the law
B. chief pharmacists who have been qualified in accordance with the law
C. pharmacists and Chinese herbalists who have been qualified in accordance with the law
D. supervisors who have been qualified in accordance with the law
D. pharmacists who have been qualified in accordance with the law
55. The Drug Manufacturing License is approved and issued by ( )
A. SFDA B. Provincial Drug Administration
C. Municipal Drug Administration D. County Drug Administration
56. Regarding the advertisement of prescription medicines, the statement is correct ( )
A. A can be introduced in the State Council administrative department of health designated medicine, pharmacy professional publications
B can be introduced in the State Council drug supervision and management department of medicine, pharmacy professional publications
C can be introduced in the Ministry of Health and the State Food and Drug Administration *** with the designated medicine, pharmacy professional publications
D shall not be advertised in all types of communication media
57. Medical institutions to formulate preparations, subject to the local ( ) review and approval by the ( ) approval, issued by the "medical institution preparation license". No "medical institution preparation license", shall not be prepared preparations. ( )
A provincial government drug supervision and management department; provincial government health administrative department
B national drug supervision and management department; provincial government drug supervision and management department
C provincial government health administrative department; provincial government health administrative department
D provincial government health administrative department; provincial government drug supervision and management department
D p>58. Examining the efficacy and adverse reactions of drugs in a wide range of conditions of use for ( )
A preclinical studies B phase I clinical trials
C phase II clinical trials D phase IV clinical trials
59. Drugs must be labeled on the inner packaging with the following information
A name of the drug, specifications, production batch B indications, dosage
C dosage, indications
C dosages, indications, dosage
C dosages, indications, indications, dosage
C dosage, indications, drug name D production lot number, adverse reactions, contraindications
60. Technology transfer of new drugs requires that the manufacturer of the technology transfer of new drugs must obtain ( )
A. "Certificate of New Drugs"
B "Drug Manufacturing License"
C. p>D "Drug Manufacturing License" and Drug "GMP" Certificate
Three, Questions and Answers
1. How long is the protection period of Chinese medicine varieties under first-class protection? What conditions should be met by Chinese medicine varieties applying for first-level protection?
2. What medicines are categorized as inferior medicines in China's Drug Administration Law?
3. Drugs are special commodities, its special characteristics are reflected in?
4. What are the drugs that cannot be advertised?
5 Article 48 of the Drug Administration Law stipulates that "the production and sale of counterfeit medicines is prohibited", and the "counterfeit medicines" mentioned here refers to?
6 What is the role of drug supervision and management?
7What are the drugs that are subject to fast-track approval when applying for a new drug?
8. What are the conditions for applying for secondary protection varieties of traditional Chinese medicine? How long is the protection period?
Reference Answers for Pharmaceutical Administration
I. Terminology Questions
1. Non-prescription Drugs: announced by SFDA, without the prescription of licensed physicians and physician assistants, consumers can judge for themselves to buy and use drugs
2. Retail Enterprises: refers to the drug business enterprises that sell purchased drugs directly to consumers
2. p>3. Applicant for drug registration: the organization that submits an application for drug registration, assumes the corresponding legal responsibility and holds the document certifying the approval of the drug after the approval of the application
4. Drug wholesaler: the drug business enterprise that sells the purchased drugs to the drug manufacturers, drug business enterprises and medical institutions
5. Prescription drugs: the drugs can be purchased, dispensed and used only with the prescription of a practicing physician or a practicing assistant. Prescription drugs: with a licensed physician and licensed physician assistant prescription can be purchased, deployment and use of drugs.
6. Narcotic drugs: refers to the continuous use of drugs that can easily produce physical dependence, addiction
7. Psychotropic drugs: refers to the direct effect on the central nervous system, so that excitation or inhibition, continuous use of drugs that can produce dependence on drugs
8. Supplementary application: refers to the application for a new drug, application for a national standard drug or application for imported drugs approved, changed, added or canceled the original application for a new drug. After the approval, change, add or cancel the original approval or the content of the application for registration
9. Included in the national drug standard drug name is also known as the generic name.
10. refers to the holder of a new drug certificate, the production technology of the new drug to the drug manufacturer, and the drug manufacturer to apply for the production of the new drug.
II. Single-choice Questions
1-5 CDACC 6-10 DBBCA 11-15 BBABB 16-20 CCABD 21-25 BBACC
26-30 DDCCA 31-35BCBDD 36-40BCCCD 41-45 BBABD 46-50 AAACB
51 -55DBAAB 56-60 CDDAD
Three Questions and Answers
1. A: 30/20/10 years respectively
Chinese medicine varieties meeting one of the following conditions can apply for the first level of protection
One with special therapeutic effects on specific diseases
Two equivalent to the first level of protection. p>2 Manufactured products equivalent to wild medicinal species under national-level protection
3 Used for the prevention and treatment of special diseases
2. A: Medicines whose contents do not comply with the national standards for medicines are considered substandard
Medicines with one of the following conditions are punished as substandard medicines
1 Failure to indicate the expiry date or change the date of expiry
2 Failure to Indicate or change the production lot number
three exceed the expiration date
four direct contact with the drug packaging materials and containers are not approved
five unauthorized addition of coloring agents, preservatives, spices, flavors and excipients
six other non-compliance with the provisions of the standard for medicines
3, the drug is a special commodity, it is reflected in the particularity of the?
Answer: a life-connecting nature of two high-quality
three public **** welfare nature of the four professional
five role of the dual nature of the six time-limited
seven varieties of production is limited
4, Answer: i. Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radiopharmaceuticals, drug rehabilitation drugs and drugs under special management identified by the State Drug Administration
Second, the State Drug Administration or provincial drug supervision and management departments ordered to stop or prohibit the production, sale and use of medicines
Third, the preparation prepared by the medical institutions
Four State Drug Administration Approved trial production of drugs
5, A: one of the following circumstances, counterfeit drugs
a drug contains ingredients that do not match the ingredients specified in the national standards for drugs
two non-drugs passed off as drugs or other kinds of drugs passed off as such drugs
with one of the following circumstances of the drugs, according to the fake drugs
a drug supervision and management department of the State Council The use of the provisions of the Drug Administration under the State Council is prohibited
Second, in accordance with this Law must be approved without approval of the production, import, or in accordance with this Law must be inspected without inspection of the sale of
Third deterioration of the contaminated four
Fifth, the use of raw materials in accordance with this Law must obtain the approval of the approval of the document number and did not obtain the approval of the document number of the production of the
Sixth, the labeled indication or function of the primary care exceeds the scope of the provisions. the prescribed scope.
6. A: First, to ensure the quality of medicines
Second, to promote the research and development of new medicines, to ensure that the development of new medicines more effective and safer.
Three to improve the competitiveness of the pharmaceutical industry, quality is the basis of competition for the survival of enterprises, but enterprises are often ignored, the government to strengthen supervision to ensure the quality, thereby improving competitiveness.
IV Regulate the drug market and ensure the supply of drugs
V Provide guarantee for the rational use of drugs and prevent drug abuse
7. Answer: i. New Chinese medicines ii. Chemical drugs not authorized to be marketed at home and abroad
3. Anti-AIDS and other drugs iv. New medicines for diseases for which no effective treatment is available
8. A: The protection period is seven years
Conforms to one of the following conditions, may apply for the second level
One meets the conditions for the first level of protection of the varieties or has been lifted from the first level of protection of the varieties
Second, the significant therapeutic effects of a specific disease
Third, the effective substances extracted from natural medicines and special preparations
Third, the effective substance of natural medicines, and special preparations