10 januari: Clinical Trial approvals

Question 1

What are the steps in MAA?

Answer 1

1) preparation dossier
2) submission
3) review by authorities
4) inspections; to verify quality and obtain data.
5) questions and answers
fun fact: takes about two years

Question 2

Why would you opt to go for either an MAA or NDA?

Answer 2

Location specific diseases e.g. gluten intolerance in Eastern Europe, specific hospitals acting as disease hotspots

Question 3

What are the FDA tasks (5)?

Answer 3

• New product review
• Post marketing surveillance
• Setting standards and writing regulations > CFR (=Code of Federal Regulations)
• Scientific research
• Regulatory enforcement and corrective action (e.g. naming and shaming)

Question 4

What are advantages of international trials? (3)

Answer 4

• Diverse subjects
• Shortens time
• Marketing advantage

Question 5

What are the types of applications in the US? (2)

Answer 5

IND: normal procedure and fast track. Getting approval to start CTs.
NDA: (&ANDA) comparable to MAA.

Question 6

When would you opt for IND fast track?

Answer 6

not ethical to wait longer without any current treatments

Question 7

When would you opt for ANDA?

Answer 7

In case of generic drugs (e.g. paracetamol, nicotine bandaid)

Question 8

If sponsor is US, and investigation site is in EU, the investigator needs to comply with… regulations.
A. FDA
B. EMA

Answer 8

A. FDA

Question 9

what is EudraCT?

Answer 9

European database for CTs which are ongoing, including all events (SUSARs etc.)

Question 10

What is EudraVigilance?

Answer 10

European database for medicinal products. also SUSARs.

Question 11

Which persons are involved in ethical committees?

Answer 11

• One physician
• one law expert
• one expert on research methodology and ethics
• patients representative
• person w/ expertise in pharmacy and clinical pharmacology

Question 12

In EU, … is given,
In US, …. is given.
A Favorable Approval
B Favorable Opinion

Answer 12

1. B

2. A