Regulatory Submissions and Approval Flashcards
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Read the first 7 Regulatory Submissions and Approval flashcards as text
Which of the following best describes the concept of 'mutual recognition' in the EU regulatory system?
Answer: A procedure where one member state's marketing authorization is recognized and extended to other member states
The Mutual Recognition Procedure (MRP) allows a marketing authorization granted by one EU Reference Member State to be recognized and extended to other Concerned Member States.
What is an eCTD (electronic Common Technical Document)?
Answer: A standardized electronic format for submitting regulatory dossiers to health authorities
The eCTD is the standard electronic format for organizing and submitting regulatory dossiers to authorities such as FDA, EMA, Health Canada, and PMDA.
Under FDA's Accelerated Approval pathway, what is required after a product receives accelerated approval?
Answer: The sponsor must conduct post-approval confirmatory trials to verify clinical benefit
Accelerated Approval requires sponsors to conduct post-approval confirmatory trials verifying clinical benefit; FDA can withdraw approval if the trials fail to confirm the benefit.
Which ICH guideline provides the international standard for Good Clinical Practice (GCP)?
Answer: ICH E6(R3)
ICH E6(R3) is the internationally harmonized guideline for Good Clinical Practice, setting standards for design, conduct, recording, and reporting of clinical trials.
A sponsor wants to make a post-approval change to a drug's manufacturing process. Which type of FDA submission is typically required for a major change?
Answer: Prior Approval Supplement (PAS)
A Prior Approval Supplement (PAS) must be submitted and approved by FDA before implementing major post-approval manufacturing changes.
In Japan, which body is primarily responsible for the scientific evaluation of new drug applications submitted through the PMDA?
Answer: PMDA with final approval granted by MHLW
PMDA conducts the scientific review and consultation, while MHLW grants the formal marketing approval (Shonin) based on PMDA's recommendation.
What is the primary objective of a regulatory gap analysis performed prior to a global submission strategy?
Answer: To identify differences in regulatory requirements across target markets that must be addressed in the dossier
A gap analysis compares the existing dossier against the specific requirements of each target market to identify missing data, format issues, or country-specific requirements.