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Global Regulatory Requirements & Standards Flashcards

7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. ICH Q8(R2) introduced which key concept for pharmaceutical development?

    Answer: Quality by Design (QbD)

    ICH Q8(R2) introduced the Quality by Design (QbD) concept, emphasizing building quality into the product through understanding and controlling the design space.

  2. Under the FDA's Drug Supply Chain Security Act (DSCSA), what is required by 2023-2024 for prescription drug products?

    Answer: Serialization and track-and-trace of product at the package level

    DSCSA requires serialization and electronic interoperable track-and-trace systems for prescription drug products to protect against counterfeiting.

  3. Which EMA procedure allows a marketing authorization to be valid in all EU member states from a single application?

    Answer: Centralized Procedure

    The Centralized Procedure results in a single marketing authorization valid throughout all EU member states, granted by the European Commission following EMA review.

  4. South Korea's MFDS (Ministry of Food and Drug Safety) generally requires which dossier format for pharmaceutical submissions?

    Answer: CTD/eCTD format

    South Korea's MFDS accepts and requires CTD/eCTD format submissions, consistent with ICH harmonization.

  5. The Mutual Recognition Agreement (MRA) between the FDA and EMA on GMP inspections primarily covers which product type?

    Answer: Human medicinal products manufactured in human drug establishments

    The FDA-EU MRA on GMP inspections covers human medicinal products manufactured at recognized drug establishments, allowing each authority to rely on the other's inspections.

  6. ICH M4 defines which regulatory submission format used globally?

    Answer: Common Technical Document (CTD)

    ICH M4 defines the organization and content of the Common Technical Document (CTD), the globally harmonized dossier format for drug marketing authorization applications.

  7. Under ICH E2C(R2), what document consolidates all pharmacovigilance data for a product at periodic intervals?

    Answer: Periodic Benefit-Risk Evaluation Report (PBRER)

    The PBRER (formerly PSUR) is submitted at defined intervals to provide a benefit-risk assessment of a marketed product based on cumulative pharmacovigilance data.