Midterm

Question 1

Drug or medicine used to treat or alleviate the symptoms of persons afflicted with a rare disease

Answer 1

Orphan Drug

Question 2

Special permit signed by the FDA director general

Answer 2

Compassionate Special Permit

Question 3

Patient Criteria

Answer 3

• Acquired Immune Deficiency Syndrome (AIDS)
• Cancer
• Life threatening conditions

Question 4

Requirements for securing CSP:

Answer 4

• Letter of application
• Name and contact details of specialist of the patient
• Prescription
• Medical abstract of the patient

Question 5

Processing time for CSP

Answer 5

15 calendar days

Question 6

Risk-based procedure for assessing unlicensed (under development) vaccines, therapeutics

Answer 6

• During public health emergencies of international concern
• Aim of expediting availability to people affected by a
public health emergency
• Based on essential set of available quality, safety, and efficacy performance data

Question 7

What are the eligibility criteria of a product to apply for an EUA?

Answer 7

• The disease may cause an outbreak, epidemic or pandemic
• No products available capable of eradicating or preventing the disease
• Products are manufactured in compliance with Good Manufacturing Practices
• Applicant undertakes to complete the development of the product and apply for pre-qualification once it is licensed

Question 8

Pfizer-BioNtech Vaccine

Answer 8

January 14, 2021

Question 9

AztraZeneca Vaccine

Answer 9

January 28, 2021

Question 10

Sinovac Vaccine

Answer 10

February 22, 2021

Question 11

CPR Validity

Answer 11

5 years

Question 12

Clinical Trial Review Period

Answer 12

90 days processing
60 days amendment
30 days import permit