RAC-USのPDF問題集リアル2026最近更新された問題
リリースRAPS RAC-US更新された問題PDF
RAPS RAC-US試験は、RAC認定プログラムの重要なコンポーネントです。 RAC-US試験は、アメリカで働く規制関連の専門家を対象に、国内の医薬品、医療機器、バイオテクノロジー産業を規制する規則や法律についてカバーしています。 RAC-US試験は、前臨床および臨床開発、品質とコンプライアンス、ポストマーケット監視、規制戦略などの規制関連のさまざまな領域における候補者の知識と専門知識を評価する120の多肢選択問題で構成されています。 RAC-US試験に合格することで、規制関連の専門家の能力が証明され、規制関連の職業分野で新しいキャリアチャンスが開かれる可能性があります。
質問 # 30
A process is ultimately validated to ensure which of the following?
- A. The process meets the regulatory requirements.
- B. The process meets the quality system requirements.
- C. The process consistently meets the desired Quantity standards
- D. The process consistently produces the desired results.
正解：D
質問 # 31
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
- A. Perform both identification and non-clinical qualification studies concurrently.
- B. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
- C. Perform either an identification study or a non-clinical qualification study.
- D. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
正解：B
質問 # 32
A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?
- A. Frequent communication
- B. Follow-up meeting after submission
- C. Early collaboration
- D. Documented agreement
正解：A
質問 # 33
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?
- A. Systematic procedure to review published scientific journals
- B. Vigilance procedure to notify the regulatory authorities about serious incidents
- C. Vigilance procedure to ensure the full traceability of the products
- D. Systematic procedure to review experiences with the products in use
正解：C
質問 # 34
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
- B. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
- C. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
- D. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
正解：B
質問 # 35
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. Prepare regulatory submissions that detail the medical device's change in materials.
- B. No action is needed in this situation.
- C. Review the content of change and supporting data for the equivalency with the current material.
- D. Write a memo to file since the change does not impact product safety and effectiveness.
正解：C
質問 # 36
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?
- A. "Product X is safe for arthritis and without side effects."
- B. "Product X is a guaranteed cure for arthritis."
- C. "Product X is effective in all patients with arthritis."
- D. "Product X is effective for the treatment of arthritis."
正解：D
質問 # 37
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?
- A. Correct the label text.
- B. Delay the start of product production.
- C. Abort the product launch.
- D. Inform the regulatory authorities.
正解：D
質問 # 38
The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?
- A. Draft a formal letter to customers in Country Y about this recall.
- B. Review alt distribution records and complaints reported in Country Y.
- C. Initiate a mandatory recall of the product in Country Y.
- D. Prepare the legal team in Country Y for possible litigations.
正解：B
質問 # 39
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?
- A. "Has the product been approved for mor&4nan 10 years?"
- B. "Is the product an established gold standard?"
- C. "Is the product profitable for the manufacturer?"
- D. "Is the product better than currently available alternatives?"
正解：D
質問 # 40
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
- A. Request documentation from the sub-contractor.
- B. Document and perform audits.
- C. Request an inspection from a regulatory authority.
- D. Ask the vendor to take responsibility.
正解：B
質問 # 41
Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?
- A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
- B. Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.
- C. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
- D. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
正解：A
質問 # 42
A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?
- A. Reformulate the products with a replacement material.
- B. Review the company's existing Quality Management System
- C. Qualify another supplier and execute a supplier agreement.
- D. Complete a gap analysis to identify options.
正解：C
質問 # 43
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject is hospitalized due to complications of the product administration.
- B. Subject is hospitalized for the purpose of product administration.
- C. Subject's hospitalization is prolonged during the clinical trial.
- D. Subject's hospitalization is due to an unscheduled hip operation.
正解：B
質問 # 44
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?
- A. Training program for sales people
- B. Local reimbursement requirements
- C. Service operation procedures
- D. Written procedure for product traceability
正解：A
質問 # 45
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 GMP
- B. Certificate of Pharmaceutical Product
- C. Certificate of Analysis for the finished product
- D. Certificate of Free Sale
正解：B
質問 # 46
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?
- A. Quality and effectiveness
- B. Safety and failure risk
- C. Quality and failure risk
- D. Safety and effectiveness
正解：D
質問 # 47
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?
- A. Results of a three-year, post-market patient survey indicate the product is superior.
- B. In vitro studies show the product to be superior.
- C. Government survey data indicate the product is superior.
- D. Results of adequate, well-controlled comparative clinical trial show the product is superior.
正解：D
質問 # 48
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase I clinical trials
- B. Phase I and II clinical trials
- C. Pre-clinical studies
- D. Phase III clinical trials
正解：D
質問 # 49
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?
- A. 3.000 total patient exposures
- B. 100 patients for 12 months
- C. 200 patients for nine months
- D. 500 patients for three months
正解：B
質問 # 50
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ガイド（2026年最新）実際のRAPS RAC-US試験問題：https://drive.google.com/open?id=1cN151_TD65lsRjaWZE4vIPRUfPpui5Po