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
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
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
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
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
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
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
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
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
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
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
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
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
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%
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
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
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
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
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
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
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
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
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
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
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
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
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
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
a. Minor
b. Major
c. Moderate
d. Relative
Answer: Minor
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