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RAPS RAC-GS Exam
Regulatory Affairs Certification (RAC) Global Scope (Page 4 )

Updated On: 7-Feb-2026
Page 4 of 21
PDF with 100 Questions

The safety database for an anti-hypertensive drug consists of the following:

· 461 patients exposed for three months
· 343 patients exposed for six months
· 112 patients exposed for nine months
· 74 patients exposed for 12 months

Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

  1. 100 patients for 12 months
  2. 200 patients for nine months
  3. 500 patients for three months
  4. 3.000 total patient exposures

Answer(s): A



A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

  1. Recommend an immediate product recall.
  2. Compare the approved text with the product label
  3. Notify the regulatory authority.
  4. Inform the production team.

Answer(s): B



According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

  1. Deficiency of a device found by the user prior to patient use
  2. Adverse event caused by patient conditions
  3. Malfunction occurring before the end of service life of the medical device
  4. Malfunction protection operated correctly

Answer(s): B,C



A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?

  1. Approved indications of the drug
  2. Determination of primary mode of action
  3. Determination of product design deliverables
  4. Guidance documents for the device

Answer(s): C



During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.
Which of the following is the most appropriate action to take FIRST?

  1. Withdraw the affected product from the markets.
  2. Send a "Dear Dr." letter to customers.
  3. Notify the global regulatory authorities.
  4. Assess the potential safety risk.

Answer(s): C



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