TRIPASS XR تري باس

 

PRACTICE QUESTIONS

Long Answer Type Questions

1. What is regulatory affairs? Explain the evolution of regulatory affairs.

2. How does government regulatory authority regulate the pharmaceutical products

in a country? Explain regulatory affairs of different countries.

3. What are the responsibilities of regulatory affairs department in a company? How

regulatory affairs department of a company related with other departments of the

company?

Short Answer Type Questions

1. How does regulatory affairs department of the company work as a bridge between

the company and the government?

2. Why regulatory affairs department is essential for the company?

3. Explain the role of regulatory affairs department of the company.

4. Explain the responsibilities of regulatory affairs professionals.

Objective Type Questions

1. All the applications for getting a pharmaceutical product approved for entering

into the market have been prepared by:

a. Regulatory affairs department b. Manufacturing department

c. Accounts department d. None of the above

Regulatory Affairs and its Role 121

2. The sulphanilamide disaster occurs in:

a. 1945 b. 1946

c. 1947 d. 1948

3. The use of which drug by pregnant women in 1956 led to phocomelia in newborn

babies:

a. Sulphanilamide b. Penicillin

c. Thalidomide d. None of the above

4. The first pharmacopoeia developed in 1581 is known as

a. German pharmacopoeia b. Spanish pharmacopoeia

c. British pharmacopoeia d. Indian pharmacopoeia

5. Introduction of Federal Food, Drugs and Cosmetics Act is enacted in:

a. 1938 b. 1939

c. 1948 d. 1949

6. Yellow card scheme was introduced in:

a. 1966 b. 1964

c. 1970 d. 1971

7. Food and Drug Administration (FDA) is drug regulatory authority of:

a. USA b. UK

c. Sweden d. India

8. MHRA is drug regulatory authority of:

 a. USA b. UK

c. Sweden d. India

9. CDSCO is drug regulatory authority of:

 a. USA b. UK

c. Sweden d. India

10. Match the following

Country Drug regulatory authority

a. Australia i. Centre for Pharmaceutical Administration Health

Sciences Authority

b. India ii. Department of Health: Pharmaceutical Services

c. Canada iii. Therapeutic Goods Administration (TGA)

d. Europe iv. Central Drug Standard Control Organization (CDSCO)

e. Singapore v. Health Canada

f. Hong Kong vi. European Medicines Agency (EMEA)

g. New Zealand vii. Irish medicines board

h. Ireland viii. Medsafe—medicines and medical devices safety authority

ANSWERS

1. a 2. c 3. c 4. b 5. a 6. b 7. a 8. b

9. b 10. a(iii), b(iv), c(v), d(vi), e(i), f(ii), g(viii), h(vii)