RAC Drugs Exam Sample Questions i,- i,- i,- i,- i,-
with Verified Answers | 100% Correct
i,- i,- i,- i,- i,- i,-
(Latest 2025/2026 Update). i,- i,-
A company is publishing an application to initiate the first clinical
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
trial involving a new investigational drug and discovers that some
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
stability results are not available. Which of the following
i,- i,- i,- i,- i,- i,- i,- i,- i,-
individuals should the publisher contact FIRST to inquire about
i,- i,- i,- i,- i,- i,- i,- i,- i,-
the missing data?
i,- i,-
1. Clinical affairs manager/director
i,- i,- i,-
2. Regulatory affairs manager/director
i,- i,- i,-
3. QC manager/director
i,- i,-
4. QA manager/director
i,- i,- i,-i,- i,- 2. Regulatory affairs
i,- i,- i,-
manager/director
Which of the following statements regarding the duties of the
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
Qualified Person (QP) responsible for batch release is correct?
i,- i,- i,- i,- i,- i,- i,- i,-
1. The QP is responsible for confirming the quality of medicinal
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
products in accordance with the requirements of the Marketing
i,- i,- i,- i,- i,- i,- i,- i,- i,-
Authorization
,2. The QP release is necessary for approved human medicinal
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
products only, not for Investigational Medicinal Products.
i,- i,- i,- i,- i,- i,-
3. The QP release does not apply for veterinary medicinal products
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
4. A signed contract agreement by the QP can waive the retesting
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
requirements of imported human medicines into the EU from a i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
country where an MRA is not in effect.i,- 1. The QP is i,- i,- i,- i,- i,- i,- i,-i,- i,- i,- i,- i,- i,-
responsible for confirming the quality of medicinal products in i,- i,- i,- i,- i,- i,- i,- i,- i,-
accordance with the requirements of the Marketing Authorization i,- i,- i,- i,- i,- i,- i,-
Your company is planning to place a generic, non-biologic
i,- i,- i,- i,- i,- i,- i,- i,- i,-
product on the market. The original product manufacturer's data
i,- i,- i,- i,- i,- i,- i,- i,- i,-
exclusivity period is over. As a regulatory professional, how will
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
you advise your company to obtain a faster Marketing
i,- i,- i,- i,- i,- i,- i,- i,- i,-
Authorisation?
1. At the outset, to commission a top-rated CRO so the necessary
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
clinical investigation reports are ready in time for applying for
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
market auth. i,-
2. To conduct bioavailability and bioequivalence studies to prove
i,- i,- i,- i,- i,- i,- i,- i,- i,-
equivalence to the original product and refer to the original i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
manufacturer's file for remaining documentation. i,- i,- i,- i,-
3. No fresh docs are required for a Marketing Authorization
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
Application (MAA) except the drug labeling, which will show a i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
different brand name than the original (which outlived it's
i,- i,- i,- i,- i,- i,- i,- i,- i,-
patent). i,-
,4. To conduct all the studies and generate the required docs as in
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
the case of a new drug, and apply for MAA under your brand
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
name. 2. To conduct bioavailability and bioequivalence
i,-i,- i,- i,- i,- i,- i,- i,- i,-
studies to prove equivalence to the original product and refer to
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
the original product manufacturer's file for the rest of the
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
documentation.
A regulatory professional receives a lengthy letter for a BLA
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
indicating non-approval. Which of the following actions will
i,- i,- i,- i,- i,- i,- i,- i,-
restart the review clock?
i,- i,- i,-
1. Initiating dispute resolution procedures
i,- i,- i,- i,-
2. Requesting rolling review
i,- i,- i,-
3. Submitting the data as available
i,- i,- i,- i,- i,-
4. Submitting the complete response
i,- i,- i,- i,- i,-i,- i,- 4. Submitting the
i,- i,- i,-
complete response i,-
A regulatory professional receives a lengthy letter for a BLA
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
indicating non-approval. Which of the following actions will
i,- i,- i,- i,- i,- i,- i,- i,-
restart the review clock?
i,- i,- i,-
1. Initiating dispute resolution procedures
i,- i,- i,- i,-
2. Requesting rolling review
i,- i,- i,-
, 3. Submitting the data as available
i,- i,- i,- i,- i,-
4. Submitting the complete response
i,- i,- i,- i,- i,-i,- i,- 4. Submitting the
i,- i,- i,-
complete response i,-
One month prior to the anticipated approval date for your
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
product, the marketing application that you submitted to a major
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
regulatory authority has become the subject of an advisory
i,- i,- i,- i,- i,- i,- i,- i,- i,-
committee meeting of experts convened by the regulatory i,- i,- i,- i,- i,- i,- i,- i,-
authority. The advisory committee members unanimously vote
i,- i,- i,- i,- i,- i,- i,-
not to approve your product because of a safety concern. Two
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
days after the advisory committee meeting, the regulatory
i,- i,- i,- i,- i,- i,- i,- i,-
authority requests additional information to support the safety of
i,- i,- i,- i,- i,- i,- i,- i,- i,-
your product. Assuming you have no additional data to provide,
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
which of the following would be your MOST appropriate
i,- i,- i,- i,- i,- i,- i,- i,- i,-
response to the regulatory authority's request?
i,- See next card i,- i,- i,- i,- i,-i,- i,- i,- i,-
1. "Given the advisory committee's unanimous decision, we know
i,- i,- i,- i,- i,- i,- i,- i,- i,-
that the product will not be approved, and additional data will
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
not make any difference.
i,- i,- i,-
2. "We have no additional information to provide at this time, but
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
we can perform an additional analysis for a specific safety
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
concern, if necessary." i,- i,-
3. "We disagree with the advisory committee's decision because
i,- i,- i,- i,- i,- i,- i,- i,- i,-
the committee neglected the thorough safety analysis that we
i,- i,- i,- i,- i,- i,- i,- i,- i,-
provided."
with Verified Answers | 100% Correct
i,- i,- i,- i,- i,- i,-
(Latest 2025/2026 Update). i,- i,-
A company is publishing an application to initiate the first clinical
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
trial involving a new investigational drug and discovers that some
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
stability results are not available. Which of the following
i,- i,- i,- i,- i,- i,- i,- i,- i,-
individuals should the publisher contact FIRST to inquire about
i,- i,- i,- i,- i,- i,- i,- i,- i,-
the missing data?
i,- i,-
1. Clinical affairs manager/director
i,- i,- i,-
2. Regulatory affairs manager/director
i,- i,- i,-
3. QC manager/director
i,- i,-
4. QA manager/director
i,- i,- i,-i,- i,- 2. Regulatory affairs
i,- i,- i,-
manager/director
Which of the following statements regarding the duties of the
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
Qualified Person (QP) responsible for batch release is correct?
i,- i,- i,- i,- i,- i,- i,- i,-
1. The QP is responsible for confirming the quality of medicinal
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
products in accordance with the requirements of the Marketing
i,- i,- i,- i,- i,- i,- i,- i,- i,-
Authorization
,2. The QP release is necessary for approved human medicinal
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
products only, not for Investigational Medicinal Products.
i,- i,- i,- i,- i,- i,-
3. The QP release does not apply for veterinary medicinal products
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
4. A signed contract agreement by the QP can waive the retesting
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
requirements of imported human medicines into the EU from a i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
country where an MRA is not in effect.i,- 1. The QP is i,- i,- i,- i,- i,- i,- i,-i,- i,- i,- i,- i,- i,-
responsible for confirming the quality of medicinal products in i,- i,- i,- i,- i,- i,- i,- i,- i,-
accordance with the requirements of the Marketing Authorization i,- i,- i,- i,- i,- i,- i,-
Your company is planning to place a generic, non-biologic
i,- i,- i,- i,- i,- i,- i,- i,- i,-
product on the market. The original product manufacturer's data
i,- i,- i,- i,- i,- i,- i,- i,- i,-
exclusivity period is over. As a regulatory professional, how will
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
you advise your company to obtain a faster Marketing
i,- i,- i,- i,- i,- i,- i,- i,- i,-
Authorisation?
1. At the outset, to commission a top-rated CRO so the necessary
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
clinical investigation reports are ready in time for applying for
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
market auth. i,-
2. To conduct bioavailability and bioequivalence studies to prove
i,- i,- i,- i,- i,- i,- i,- i,- i,-
equivalence to the original product and refer to the original i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
manufacturer's file for remaining documentation. i,- i,- i,- i,-
3. No fresh docs are required for a Marketing Authorization
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
Application (MAA) except the drug labeling, which will show a i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
different brand name than the original (which outlived it's
i,- i,- i,- i,- i,- i,- i,- i,- i,-
patent). i,-
,4. To conduct all the studies and generate the required docs as in
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
the case of a new drug, and apply for MAA under your brand
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
name. 2. To conduct bioavailability and bioequivalence
i,-i,- i,- i,- i,- i,- i,- i,- i,-
studies to prove equivalence to the original product and refer to
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
the original product manufacturer's file for the rest of the
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
documentation.
A regulatory professional receives a lengthy letter for a BLA
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
indicating non-approval. Which of the following actions will
i,- i,- i,- i,- i,- i,- i,- i,-
restart the review clock?
i,- i,- i,-
1. Initiating dispute resolution procedures
i,- i,- i,- i,-
2. Requesting rolling review
i,- i,- i,-
3. Submitting the data as available
i,- i,- i,- i,- i,-
4. Submitting the complete response
i,- i,- i,- i,- i,-i,- i,- 4. Submitting the
i,- i,- i,-
complete response i,-
A regulatory professional receives a lengthy letter for a BLA
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
indicating non-approval. Which of the following actions will
i,- i,- i,- i,- i,- i,- i,- i,-
restart the review clock?
i,- i,- i,-
1. Initiating dispute resolution procedures
i,- i,- i,- i,-
2. Requesting rolling review
i,- i,- i,-
, 3. Submitting the data as available
i,- i,- i,- i,- i,-
4. Submitting the complete response
i,- i,- i,- i,- i,-i,- i,- 4. Submitting the
i,- i,- i,-
complete response i,-
One month prior to the anticipated approval date for your
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
product, the marketing application that you submitted to a major
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
regulatory authority has become the subject of an advisory
i,- i,- i,- i,- i,- i,- i,- i,- i,-
committee meeting of experts convened by the regulatory i,- i,- i,- i,- i,- i,- i,- i,-
authority. The advisory committee members unanimously vote
i,- i,- i,- i,- i,- i,- i,-
not to approve your product because of a safety concern. Two
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
days after the advisory committee meeting, the regulatory
i,- i,- i,- i,- i,- i,- i,- i,-
authority requests additional information to support the safety of
i,- i,- i,- i,- i,- i,- i,- i,- i,-
your product. Assuming you have no additional data to provide,
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
which of the following would be your MOST appropriate
i,- i,- i,- i,- i,- i,- i,- i,- i,-
response to the regulatory authority's request?
i,- See next card i,- i,- i,- i,- i,-i,- i,- i,- i,-
1. "Given the advisory committee's unanimous decision, we know
i,- i,- i,- i,- i,- i,- i,- i,- i,-
that the product will not be approved, and additional data will
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
not make any difference.
i,- i,- i,-
2. "We have no additional information to provide at this time, but
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
we can perform an additional analysis for a specific safety
i,- i,- i,- i,- i,- i,- i,- i,- i,- i,-
concern, if necessary." i,- i,-
3. "We disagree with the advisory committee's decision because
i,- i,- i,- i,- i,- i,- i,- i,- i,-
the committee neglected the thorough safety analysis that we
i,- i,- i,- i,- i,- i,- i,- i,- i,-
provided."
