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Free RAC-GS Exam Braindumps
Regulatory Affairs Certification (RAC) Global Scope Questions 41–45 (page: 10)

Updated On: 9-Feb-2026
Page 10 of 21
PDF with 100 Questions

Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

  1. "Is the product profitable for the manufacturer?"
  2. "Is the product better than currently available alternatives?"
  3. "Has the product been approved for mor&4nan 10 years?"
  4. "Is the product an established gold standard?"

Answer(s): B



Which of the following situations does NOT require rapid communication to regulatory authorities?

  1. A clinically important increase in the rate of occurrence of an "expected." but serious ADR
  2. A lack of efficacy with a medicinal product used in treating a life-threatening disease
  3. A major safety finding from a newly completed animal carcinogenicity study
  4. A statistically significant increase in the number of deaths in an animal dose finding study

Answer(s): A,D



A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the WHO recommendations?

  1. Certificate of GMP
  2. Certificate of Free Sale
  3. Certificate of Pharmaceutical Product
  4. Certificate of Analysis for the finished product

Answer(s): C



A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

  1. Ask the trade association representative to provide an overview of the new product area to the marketing team.
  2. Obtain competitor research and provide the information to the management team.
  3. Obtain regulatory documents and history and provide the information to R&D.
  4. Summarize regulatory documents and history and provide the information to the management team.

Answer(s): D



During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

  1. Allow the auditor access to the room and records due to the current audit.
  2. Allow the auditor accompanied access to the room to retrieve the records.
  3. Deny the auditor access to the room and retrieve only the requested records.
  4. Deny the auditor access to the room and records due to confidentiality concerns.

Answer(s): B



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