February 22, 2024

804ET MCQ Pharmaceutical Regulatory Science Theory MCQ

BP804ET Pharmaceutical Regulatory Science Theory MCQ

Chapterwise MCQ

Unit I MCQ: New Drug Discovery and development MCQ

Unit II MCQ: Regulatory Approval Process MCQ

Unit III MCQ: Registration of Indian drug products in the overseas market MCQ

Unit IV MCQ: Clinical trials MCQ

Unit V MCQ: Regulatory Concepts MCQ

Mix MCQ: Pharmaceutical Regulatory Science MCQ

1. Select the responsibility/s of RA personnel
a. To analyze the content of the active ingredient in the formulation
b. Work with federal, state and local governing agencies to get the approval for drug
c. To undertake stability studies of the drug products
d. To supervise the production of the formulation

Answer: Work with federal, state and local governing agencies to get the approval for drug

2. How many drugs can be imported under single Form11 license?
a. 20
b. 5
c. 10
d. 15

Answer: 10

3. List of approved drugs and their associated IPR is available in __
a. Pink book
b. Orange book
c. Red book
d. Black book

Answer: Orange book

4. Identify the relevant regulatory body in USFDA for approval of drugs.
a. BLA
b. IND
c. CBER
d. CDER

Answer: CDER

5. In US the Orphan Drug Exclusivity (ODE) last for ……years
a. 5
b. 6
c. 7
d. 8

Answer: 7

6. In Europe, variations are classified as Type-IA for …………change
a. Minor
b. Major
c. Moderate
d. Relative

Answer: Minor

7. …….. are the committees related to EU Regulations
a. TGA
b. CDER
c. CBER
d. COMP

Answer: COMP

8. The “Certificate of Suitability” as per EU guidelines is valid for…… years from the date
when the original certificate was granted.
a. 5
b. 10
c. 15
d. 20

Answer: 5

9. CTD is divided into …..modules
a. 3
b. 4
c. 5
d. 6

Answer: 5

10. Schedule ……..of the D&C Act 1940 and Rules 1945 deals with the guidelines for Good
Manufacturing Practices
a. Y
b. M
c. P
d. X

Answer: M

11. The entry in Batch Manufacturing Record is done by
a. Quality control department
b. Quality assurance department
c. Warehouse department
d. Production department

Answer: Production department

12. In pharmacovigilance, the term ADR stands for _
a. Adverse Drug Reaction
b. Adverse Dose Reaction
c. Absolute Drug Reaction
d. Absolute Dose Reaction

Answer: Adverse Drug Reaction

13. BCS classification for Class III drugs is
a. High solubility high permeability
b. Low solubility high permeability
c. High solubility low permeability
d. Low solubility Low permeability

Answer: High solubility low permeability

14. As per ANDA requirements, the bioequivalence of test to reference formulation is
a. 80-120%
b. 100-150%
c. 70-130%
d. 70-80%

Answer: 80-120%

15. Which of the following is regulatory authority of Australia
a. Pharmaceutical and Medical Devices Agency
b. Therapeutic Goods Administration
c. Medicines and Healthcare Products Regulatory Agency
d. Central Drug Standard Control Organization

Answer: Therapeutic Goods Administration

16. Which of the following is an International regulatory authority for drug regulation
a. CDSCO
b. WHO
c. UNESCO
d. EMA

Answer: WHO

17. The oldest quality control laboratory of the Drug Control Authorities in India is
a. Central Drugs Testing Laboratory, Kolkata
b. Central Drugs Testing Laboratory (CDTL) Chennai , Tamil Nadu
c. Central Drugs Testing Laboratory (CDTL) Hyderabad, AP
d. Central Drugs Testing Laboratory (CDTL), Mumbai

Answer: Central Drugs Testing Laboratory, Kolkata

18. Which of the following is a branch of CDL
a. New Delhi
b. Kolkata
c. Faridabad
d. Bangalore

Answer: Kolkata

19. Indian Pharmacopoeia Commission headquarter is located at
a. Delhi
b. Mumbai
c. Hyderabad
d. Ghaziabad

Answer: Ghaziabad

20. Central drug Testing Laboratory is located at _
a. Mumbai
b. Delhi
c. Bangalore
d. Lucknow

Answer: Mumbai

21. The 1st edition of Indian Pharmacopoeia was published in the year
a. 1966
b. 1955
c. 1950
d. 1960

Answer: 1955

22. The objective of FDA- India office is
a. To ensure the safety, quality, and effectiveness of medical products and food
produced in India for export to the United States.
b. Approval of medical products for marketing in India
c. Import of drug in India for test and examination
d. Manufacture of drugs in USA for the purpose of export to India

Answer: Approval of medical products for marketing in India

23. The chairman of Indian Pharmacopoeial commission is
a. Chairman-Scientific Body
b. The Drugs Controller General
c. Directorate General of Health Services
d. The Secretary, Ministry of Health and Family Welfare

Answer: The Secretary, Ministry of Health and Family Welfare

24. . How many drugs can be imported under a single Form11 license?
a. 20
b. 5
c. 10
d. 15

Answer: 10

25. . List of approved drugs and their associated IPR is available in __
a. Pink book
b. Orange book
c. Red book
d. Black book

Answer: Orange book

26. Identify the relevant regulatory body in USFDA for approval of drugs.
a. BLA
b. IND
c. CBER
d. CDER

Answer: CDER

27. In US the Orphan Drug Exclusivity (ODE) last for ……years
a. 5
b. 6
c. 7
d. 8

Answer: 7

28. In Europe, variations are classified as Type-IA for …………change
a. Minor
b. Major
c. Moderate
d. Relative

Answer: Minor


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