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.
Read the first 7 Global Regulatory Requirements & Standards flashcards as text
Which regulation governs the post-market surveillance obligations for medical device manufacturers in the European Union?
Answer: EU MDR 2017/745
EU MDR 2017/745 establishes comprehensive post-market surveillance requirements for medical device manufacturers operating in the EU.
Under 21 CFR Part 11, what is required for electronic records to be considered equivalent to paper records?
Answer: Audit trails, system validation, and controlled access with user authentication
21 CFR Part 11 requires audit trails, system validation, and access controls with unique user IDs and passwords for electronic records to be considered reliable equivalents to paper records.
ICH E6(R2) and the emerging E6(R3) guidelines cover which regulatory domain?
Answer: Good Clinical Practice (GCP)
ICH E6 provides the GCP guidelines that define the responsibilities and standards for conducting clinical trials.
Health Canada's Notice of Compliance (NOC) is equivalent to which US regulatory action?
Answer: NDA approval
An NOC from Health Canada grants market authorization for a new drug, equivalent to FDA approval of an NDA.
Which global standard defines requirements for Quality Management Systems in medical device manufacturing?
Answer: ISO 13485
ISO 13485 specifies QMS requirements specific to the medical device industry and is recognized by regulators worldwide.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) primarily facilitates what regulatory activity?
Answer: Harmonization of GMP standards and mutual acceptance of GMP inspections
PIC/S works to harmonize GMP standards and foster mutual recognition of inspection outcomes among participating regulatory authorities.
In Brazil, ANVISA's product registration pathway for 'novo' (new) medicines requires submission of which dossier format?
Answer: CTD format adapted to ANVISA requirements via Datavisa
Brazil's ANVISA uses an adapted CTD format submitted through its Datavisa electronic system for new drug product registrations.