[2026] Use Valid New RAC-GS Questions - Top choice Help You Gain Success
RAC-GS Exam Practice Materials Collection
The RAC-GS exam is administered by the Regulatory Affairs Professionals Society (RAPS), and it is tailored specifically to professionals who work in the global regulatory landscape. RAC-GS exam is designed to assess an individual's knowledge of regulatory affairs in a variety of international markets, including the United States, Europe, and Asia. The RAC-GS certification is highly respected in the industry, and it can help individuals advance their careers, increase their earning potential, and demonstrate their commitment to the field of regulatory affairs.
The RAC-GS exam is designed to test the knowledge and skills of regulatory professionals in a variety of areas, including global regulatory requirements, product development, regulatory submissions, and post-market surveillance. RAC-GS exam is divided into four main sections: Global Regulatory Environment, Product Development, Regulatory Submissions, and Post-Market Surveillance. Each section is designed to test a candidate's understanding of the key concepts and practices related to regulatory affairs, and the exam is designed to be challenging and comprehensive.
NEW QUESTION # 48
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood
glucose self-testing kit?
- A. Class A
- B. Class D
- C. Class C
- D. Class B
Answer: C
NEW QUESTION # 49
A company is currently marketing an implantable orthopedic medical device. The R&D department is
planning to change the material used for the implant. The R&D department states that the change does
not impact the safety and effectiveness of the product. What action should the regulatory affairs
professional take FIRST?
- A. No action is needed in this situation.
- B. Write a memo to file since the change does not impact product safety and effectiveness.
- C. Review the content of change and supporting data for the equivalency with the current material.
- D. Prepare regulatory submissions that detail the medical device's change in materials.
Answer: C
NEW QUESTION # 50
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?
- A. 30c C and 65% RH
- B. 30 C and 35% RH
- C. 30: C and 75% RH
- D. 25: C and 60% RH
Answer: C
NEW QUESTION # 51
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on
the part of the PI. What action should the sponsor take?
- A. Increase the frequency of monitoring visits.
- B. Inform the institution that granted a medical license to the Pi.
- C. Send a letter of complaint to the Ethics Committee that approved the site.
- D. Terminate the PI and inform the regulatory authorities.
Answer: D
NEW QUESTION # 52
A company is developing a new product for the global market. A new international guideline will
recommend relevant studies in the pediatric population, and the guideline will be effective before the
approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this
guideline on the successful registration of the new product?
- A. The new guideline has no impact on the current registration plan since all relevant registration studies
are almost completed. - B. The new guideline has no impact on the current registration plan, but the company must be prepared to
defend its decision. - C. The company should initiate the required pediatric studies immediately to avoid costly delays to the
current registration plan. - D. The company should consult with relevant regulatory authorities to determine the potential impact on
the current registration plan.
Answer: D
NEW QUESTION # 53
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?
- A. Send a "Dear Dr." letter to customers.
- B. Withdraw the affected product from the markets.
- C. Notify the global regulatory authorities.
- D. Assess the potential safety risk.
Answer: C
NEW QUESTION # 54
During a routine review of promotional materials for a product, a regulatory affairs professional discovers
an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory
affairs professional to take?
- A. Allow doctors to use the product for the off-label indication.
- B. Request that doctors stop using the product for the off-label indication.
- C. Communicate with the sales department to stop using the promotional materials.
- D. Contact the marketing department to recall the product.
Answer: C
NEW QUESTION # 55
In order to develop a global drug product, what is the MOST important environmental characteristic to
consider in the country of intended use?
- A. Product formulation
- B. Product registration
- C. Product requirements
- D. Product stability
Answer: D
NEW QUESTION # 56
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional
who wants to provide feedback on proposed new regulations?
- A. After the enactment of the regulation, through the industry representative
- B. Before the enactment of the regulation, through the industry representative
- C. Before the enactment of the regulation, through formal comments gathering process
- D. After the enactment of the regulation, through a product-specific meeting
Answer: C
NEW QUESTION # 57
Which of the following BEST describes the process of post-marketing surveillance for healthcare
products?
- A. Systematic procedure to review experiences with the products in use
- B. Systematic procedure to review published scientific journals
- C. Vigilance procedure to notify the regulatory authorities about serious incidents
- D. Vigilance procedure to ensure the full traceability of the products
Answer: D
NEW QUESTION # 58
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a
holiday season when most of the staff Is not available. What is the MOST practical approach to this
dilemma?
- A. Inform the authority that the time is not suitable and request a new time
- B. Insist that key personnel be available for the inspection.
- C. Negotiate with colleagues and the authority to find a better time.
- D. Arrange for an inspection without all intended personnel.
Answer: C
NEW QUESTION # 59
Which of the following claims would classify an apple as a drug?
- A. "It will prevent colds."
- B. "It will make you look younger."
- C. "It will whiten teeth."
- D. "It will satisfy hunger."
Answer: A
NEW QUESTION # 60
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory
affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
- A. Communicate with the relevant internal departments.
- B. Request a permanent waiver from the new regulation.
- C. Contact the trade association for advice.
- D. Prepare documents for the files.
Answer: A
NEW QUESTION # 61
Which of the following is the PRIMARY purpose of an audit report?
- A. To document compliance history
- B. To carry out a complete review of product applications
- C. To train sales representatives
- D. To define how to prepare new product submissions
Answer: A
NEW QUESTION # 62
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of
the SOP Is MOST important to consider?
- A. Relevance to regulations
- B. Revision history
- C. Expiration date
- D. Scope and level of detail
Answer: A
NEW QUESTION # 63
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Distributor
- B. Manufacturer
- C. Regulatory authority
- D. Consumer
Answer: B
NEW QUESTION # 64
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?
- A. Certificate of Pharmaceutical Product
- B. Certificate of GMP
- C. Certificate of Analysis for the finished product
- D. Certificate of Free Sale
Answer: A
NEW QUESTION # 65
Company X encounters challenges in the global life cycle management of its medical devices. Which of
the following Is MOST appropriate for improving product life cycle management?
- A. Identify countries where special requirements exist during the product development phase.
- B. Initiate a global submission process after all submission data are finalized.
- C. Utilize the STED template to complete global requirements.
- D. Plan regulatory approval update meetings with senior management and stakeholders.
Answer: A
NEW QUESTION # 66
Which of the following changes to a drug product is MOST likely to be implemented without prior
regulatory authority approval?
- A. Deleting a drug substance
- B. Introducing a new analytical method
- C. Deleting an ingredient of the drug product
- D. Strengthening a precaution to the product labeling
Answer: D
NEW QUESTION # 67
The API used for an approved drug product conforms to international monograph specifications and local
pharmacopeia; however, the international monograph specifications of the API will be changing soon.
Which is the most appropriate action for the regulatory affairs professional to take FIRST?
- A. Transfer the notice of the upcoming international monograph change to QA for further processing.
- B. Confirm that the international monograph change is not related to local pharmacopeia.
- C. Prepare the international monograph change submission first and then prepare the local change when
required. - D. Analyze the impact of the international monograph change on the local pharmacopeia.
Answer: A
NEW QUESTION # 68
Company X and Company Y both have products for the treatment of rare genetic diseases. Company X
would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about
Company Y?
- A. Perform a thorough library search to gather detailed information on Company Y.
- B. Request the needed information from the Board of Directors of Company Y.
- C. Recruit a professional to gather confidential intelligence on Company Y.
- D. Enter into an agreement with Company Y to perform due diligence.
Answer: D
NEW QUESTION # 69
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product
does not meet one of the specific technical requirements of the regulation. However, competitors with
substantially similar products have claimed compliance with the requirement and received approval.
Which action should the regulatory affairs professional take FIRST?
- A. Notify senior management that the product cannot be registered.
- B. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
- C. Inform the internal departments to redesign the product to comply with this requirement.
- D. Inform the regulatory authority that such a requirement is not applicable to the product.
Answer: B
NEW QUESTION # 70
A clinical study of a drug is completed to support a marketing approval application. According to ICH, how
long should a sponsor retain the clinical study essential documents?
- A. Until the product has been discontinued from marketing in all ICH regions
- B. For at least two years after the last approval of an application in an ICH region
- C. Three years after the last clinical study site was supplied with investigational drugs
- D. For a minimum of 10 years after completion of the clinical study
Answer: B
NEW QUESTION # 71
One month prior to the anticipated approval date for your product, the marketing application that you
submitted to a major regulatory authority has become the subject of an advisory committee meeting of
experts convened by the regulatory authority. The advisory committee members unanimously vote not to
approve your product because of a safety concern. Two days after the advisory committee meeting, the
regulatory authority requests additional information to support the safety of your product. Assuming you
have no additional data to provide, which of the following would be your MOST appropriate response to
the regulatory authority's request?
- A. "We have no additional information to provide at this time, but we can perform an additional analysis for
a specific safety concern, if necessary." - B. "Given the advisory committee's unanimous decision, we know that the product will not be approved,
and additional data will not make any difference." - C. "We have no additional information to provide at this time because we have already provided
everything needed to support our product's approval." - D. "We disagree with the advisory committee's decision because the committee neglected the thorough
safety analysis that we provided."
Answer: A
NEW QUESTION # 72
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