RAC-GS Online Practice Questions and Answers

A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X. where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y. The company is proposing to start marketing the coated device in Country Y. Which regulatory approach should the company propose?

A. Submit the product for review as a pharmaceutical product in Country Y.

B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

C. Apply for review of the additional part of the product as a pharmaceutical product in Country

D. Examine decisions made about similar products in Country Y to propose the classification ofthe product.

After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

A. Resubmit the entire package.

B. Inform upper management immediately.

C. Contact the legal department and ask them how to proceed.

D. Verify the procedure in the regulation for the corrections.

A global company has obtained a patent in a specific country for a newly marketed product. What would be the BEST advice In order to protect the patent in other countries?

A. Use the Madrid system.

B. Use the community patent system.

C. File patents of interest in target countries.

D. File design patents in target countries.

According to the ICH guideline on GMP for API,to which of the following is the MOST stringent requirement applied?

A. Physical processing and packaging

B. Isolation and purification

C. Production of Intermediate(s)

D. Introduction of the API starting material

During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

A. ISO 14971 risk analysis

B. Failure mode and effect analysis

C. Fault tree analysis

D. Hazard and operability study

A company is currently marketing an implantable orthopedic medical device. The RandD department is planning to change the material used for the implant. The RandD 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. Prepare regulatory submissions that detail the medical device's change in materials.

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.

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. Discuss with the regulatory apriority and attempt to reach an acceptable solution.

B. Inform the internal departments to redesign the product to comply with this requirement.

C. Inform the regulatory authority that such a requirement is not applicable to the product.

D. Notify senior management that the product cannot be registered.

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 analytical result of Company X API

B. The process information and analytical result of Company Y API

C. The process information and the comparative analytical result of APIs from both companies

D. Information deemed appropriate by the regulatory authority