Global Regulatory Requirements & Standards Flashcards

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

Answer: ICH Q1A(R2)

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

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

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.

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

Answer: Both MHLW and PMDA have roles

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

The WHO Prequalification Programme primarily serves which purpose?

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.

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

Answer: Parallel submission

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

Under CDSCO (India) regulations, what is the SUGAM portal used for?

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.

The ASEAN Common Technical Dossier (ACTD) format is based on which internationally harmonized format?

Answer: CTD (Common Technical Document)

The ACTD is adapted from the ICH CTD format and used for pharmaceutical registrations across ASEAN member states.