CRAP Global Regulatory Requirements & Standards 2

Question 1

Which ICH guideline specifically addresses the stability testing of new drug substances and products?

Accepted Answer

ICH Q1A(R2)

Answer

ICH Q1A(R2) provides guidance on stability testing of new drug substances and drug products.

Question 2

Under the EU Clinical Trials Regulation (CTR) 536/2014, which portal is used for clinical trial applications across EU member states?

Accepted Answer

CTIS (Clinical Trials Information System)

Answer

CTIS is the single-entry portal established by EU CTR 536/2014 for submitting and managing clinical trial applications across the EU.

Question 3

In Japan, which regulatory body is responsible for approving pharmaceutical products and medical devices?

Accepted Answer

Both MHLW and PMDA have roles

Answer

In Japan, PMDA conducts the review and MHLW grants the final marketing authorization approval.

Question 4

The WHO Prequalification Programme primarily serves which purpose?

Accepted Answer

Evaluating medicines for procurement by UN agencies and low-income countries

Answer

WHO Prequalification evaluates the quality, safety, and efficacy of medicines intended for procurement by UN agencies and use in low-income countries.

Question 5

Which concept in global regulatory strategy involves submitting applications in multiple countries simultaneously to reduce time-to-market?

Accepted Answer

Parallel submission

Answer

Parallel submission involves filing regulatory applications in multiple jurisdictions at the same time to shorten the overall approval timeline.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Global Regulatory Requirements & Standards 2