CRAP Global Regulatory Requirements & Standards 1

Question 1

Which organization manages drug approvals in the EU?

Accepted Answer

EMA

Answer

FDA

Answer

MHRA

Answer

CDC

Question 2

What is ICH?

Accepted Answer

International Council for Harmonisation

Answer

Institute for Clinical Health

Answer

International Commission for Health

Answer

Independent Clinical Hub

Question 3

Which document format is used globally for submissions?

Accepted Answer

CTD

Answer

DPI

Answer

ADR

Answer

OTC

Question 4

Which country uses PMDA for regulatory oversight?

Accepted Answer

Japan

Answer

South Korea

Answer

India

Answer

Germany

Question 5

What is the purpose of harmonized regulatory standards?

Accepted Answer

Simplify submissions and reduce duplication

Answer

Increase approval delays.

Answer

Protect patents globally.

Answer

Exclude small companies.

Question 6

Which ISO standard focuses on quality management for medical devices?

Accepted Answer

ISO 13485

Answer

ISO 9001

Answer

ISO 14001

Answer

ISO 17025

Question 7

What role does Health Canada play?

Accepted Answer

Evaluates drugs and devices in Canada

Answer

Distributes vaccines globally.

Answer

Files taxes.

Answer

Manages hospitals.

Question 8

Which region uses the TGA for regulatory approvals?

Accepted Answer

Australia

Answer

Brazil

Answer

Mexico

Answer

New Zealand

Question 9

Why are regional regulatory requirements important?

Accepted Answer

To ensure compliance with local laws

Answer

To avoid inspections.

Answer

To reduce clinical trials.

Answer

To delay product reviews.