QUESTION: 29

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 the antibiotics 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?

Submit the product for review as a pharmaceutical product in Country Y.
Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
Apply for review of the additional part of the product as a pharmaceutical product in Country
Examine decisions made about similar products in Country Y to propose the classification of the product.

Answer(s): C

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QUESTION: 30

The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

Production
Analytical
Quality
Regulatory

Answer(s): C

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QUESTION: 31

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?

Approved indications of the drug
Determination of primary mode of action
Determination of product design deliverables
Guidance documents for the device

Answer(s): C

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QUESTION: 32

Which of the following BEST describes the purpose of the ICH?

To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions
To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions
To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions
To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

Answer(s): D

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QUESTION: 29

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QUESTION: 32