Daily Practice of Regulations-Physical Examination of Licensed Pharmacists in Tianjin in 2020 (May 7, 2020)

Practice "Regulations" Every Day —— Licensed Pharmacists for Physical Examination in Tianjin in 2020

47. It is incorrect to say that the listing licensee system is a pilot scheme.

A. The pilot of the marketing license holder system allows R&D institutions and researchers to obtain drug approval numbers.

B the pilot authorization period of the market licensing system for listing license holders is three years.

C. The legal responsibilities related to drug clinical trials, drug production and sales stipulated by laws and regulations shall be borne only by the applicant.

D. If the holder has production qualification, he may entrust production.

48. Approved for listing in China, the reference drugs used for generic drug registration application belong to

A. Reference reagent B. Standard reagent

C. Drug equivalence D. Treatment equivalence

49. Regarding the registration and classification of drugs, biological products are divided into

A.9 category B. 10 category

C. 15 class D.5 class

Second, compatibility multiple-choice questions

[50~5 1]

A. 1 class B.2

C.3 level D.4 level

50. According to the Announcement on Printing and Distributing the Reform Plan of Chemical Drug Registration and Classification, the improved new drugs that are not listed at home and abroad are

5 1. According to the Announcement on Issuing the Reform Plan for Registration and Classification of Chemical Drugs, the drugs that domestic applicants copy the original research drugs that have been listed in China are

[52~55]

A. Phase I clinical trial B. Phase II clinical trial

C. Phase C.III clinical trials d. IV clinical trials

52. Belong to the preliminary clinical pharmacology and human safety evaluation test is

53. Belonging to the initial evaluation stage of treatment effect are

54 belongs to the stage of confirming curative effect, which provides sufficient basis for the examination of drug registration application.

55. Check the efficacy and adverse reactions of drugs under the conditions of extensive use.

[56~57]

A. New drug application B. Supplementary application

C. Application for generic drugs D. Application for imported drugs

56. The application for registration of drugs not listed and sold inside and outside China belongs to

57. The drug applied for registration is consistent with the quality and efficacy of the original drug, belonging to

[58~60]

A. Drug production license B. Import drug registration certificate

C. Medical product registration certificate D. Practice license of medical institution

58. Drugs produced by enterprises in China, Hongkong, Macao and Taiwan Province provinces must be held at the port where the drug supervision and administration department is located.

59. Drugs produced by foreign enterprises must be held at the port registered by the pharmaceutical supervisory and administrative department.

60. If a foreign drug that has been sold in China fails to apply for re-registration at the expiration of its drug certification, it shall be cancelled.

Reference answer and analysis?

47. Answer C. Analysis: This question examines the knowledge points of the pilot of the listing permit holder system in the clinical trial stage. The legal responsibilities related to drug clinical trials, drug production and sales stipulated by laws and regulations shall be borne by the applicant and the holder accordingly, so C is selected for this question.

48. Answer A. Analysis: This question examines the knowledge points of related terms in the drug list listed in China. The reference drugs approved for listing in China and used in generic drug registration application belong to reference reagents, so this question chooses A.

49. Answer C. Analysis: This question examines the knowledge points of drug registration and classification. The registration of biological products is divided into 15 categories, so this question is selected as C.

Second, compatibility multiple-choice questions

[50 ~ 5 1] answer BD. Analysis: This topic mainly examines the registration and classification of chemicals. There are two kinds of improved new drugs that are not listed at home and abroad, and four kinds of domestic applicants imitate the original drugs that have been listed in China.

[52 ~ 55] Answer ABCD. Analysis: This topic mainly examines the clinical trials of drugs. Phase I clinical trial belongs to the preliminary clinical pharmacology and human safety evaluation test, phase II clinical trial belongs to the preliminary evaluation stage of curative effect, phase III clinical trial belongs to the confirmation stage of curative effect, and phase IV clinical trial provides sufficient basis for the evaluation of drug registration application, and investigates the curative effect and adverse reactions of drugs under the condition of wide use.

[56 ~ 57] The answer is AC. Analysis: This question mainly examines the classification of drug registration applications. The application for registration of drugs that are not listed and sold at home and abroad belongs to the application for new drugs. An application for drug registration with the same quality and efficacy as the original drug is a generic drug application. So choose a and C.

[58 ~ 60] Answer CBB. Analysis: This question mainly examines the drug approval number. Imported drugs produced by foreign enterprises shall obtain the Registration Certificate of Imported Drugs, and imported drugs produced by enterprises in Hong Kong, Macao and Taiwan shall obtain the Registration Certificate of Pharmaceutical Products.

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