CRAP Global Regulatory Requirements & Standards 2 — Questions and Answers
Question 1: Which ICH guideline specifically addresses the stability testing of new drug substances and products?
- ICH Q1A(R2) (Correct answer)
- ICH Q3A(R2)
- ICH Q6A
- ICH S1A
Correct answer: ICH Q1A(R2)
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?
- EudraVigilance
- CTIS (Clinical Trials Information System) (Correct answer)
- EMA Connect
- CESP portal
Correct answer: CTIS (Clinical Trials Information System)
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?
- MHLW only
- PMDA only
- Both MHLW and PMDA have roles (Correct answer)
- TGA
Correct answer: Both MHLW and PMDA have roles
In Japan, PMDA conducts the review and MHLW grants the final marketing authorization approval.
Question 4: The WHO Prequalification Programme primarily serves which purpose?
- Approving drugs for sale in EU markets
- Evaluating medicines for procurement by UN agencies and low-income countries (Correct answer)
- Replacing national drug approvals globally
- Setting ICH guidelines for biologics
Correct answer: Evaluating medicines for procurement by UN agencies and low-income countries
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?
- Rolling review
- Work-sharing
- Parallel submission (Correct answer)
- Mutual recognition
Correct answer: Parallel submission
Parallel submission involves filing regulatory applications in multiple jurisdictions at the same time to shorten the overall approval timeline.
Question 6: Under CDSCO (India) regulations, what is the SUGAM portal used for?
- Tracking adverse events
- Online submission of regulatory applications for drugs and devices (Correct answer)
- Publishing approved drug lists
- Managing import licenses only
Correct answer: Online submission of regulatory applications for drugs and devices
SUGAM is CDSCO's online portal for submitting and tracking regulatory applications for drugs, biologics, and medical devices in India.
Question 7: The ASEAN Common Technical Dossier (ACTD) format is based on which internationally harmonized format?
- NDA format
- CTD (Common Technical Document) (Correct answer)
- PLA format
- eCTD format only
Correct answer: CTD (Common Technical Document)
The ACTD is adapted from the ICH CTD format and used for pharmaceutical registrations across ASEAN member states.
CRAP Global Regulatory Requirements & Standards 2
Which ICH guideline specifically addresses the stability testing of new drug substances and products?