RAPS Regulatory Affairs Certification (RAC) US 認定 RAC-US 試験問題:
1. A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
A) Request a meeting with the regulatory authority to discuss the application.
B) Review the regulatory guidelines to determine how to proceed.
C) Consult with the legal department to discuss the best course of action.
D) Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
2. A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
A) Justification
B) Formulation
C) Specification
D) Property
3. 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 B
C) Class D
D) Class C
4. The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?
A) The process information and the comparative analytical result of APIs from both companies
B) The process information and analytical result of Company Y API
C) The process information and analytical result of Company X API
D) Information deemed appropriate by the regulatory authority
5. 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 a minimum of 10 years after completion of the clinical study
C) Three years after the last clinical study site was supplied with investigational drugs
D) For at least two years after the last approval of an application in an ICH region
質問と回答：
| 質問 # 1 正解： A | 質問 # 2 正解： A | 質問 # 3 正解： D | 質問 # 4 正解： A | 質問 # 5 正解： D |
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