RAPS RAC (Drug) Practice Test WITH
CORRECT QUESTIONS AND ANSWERS
2025/2026
- correct answers
A biotechnology company is developing a follow-on biologic it claims is similar to an authorised
biologic medicinal product and already available on the market. What should the regulatory
professional submit with the Marketing Authorisation Application dossier? - correct answers Full
quality dossier supplemented by the demonstration of comparability.
A clinical investigator would like to use an investigational medicinal product to treat a gravely ill
patient who does not meet the protocol inclusion criteria. However, in the expert opinion of the
clinical investigator, the product would be the best option for that patient. What action is MOST
appropriate for the clinical investigator to take? - correct answers Obtain approval from the CA
for compassionate use of the product for this particular patient.
A clinical trial for a medicinal product was conducted in several European countries and has
been finalized. What is the MOST appropriate next regulatory step? - correct answers File a
declaration on the end of the clinical trial to the CA and ethics committees of the participating
countries.
A company has a product on the market in Country X. To ensure successful launch of the
product in Country Y, which of the following resources should be examined FIRST? - correct
answers Country Y's regulatory agency website.
, A company is developing a new chemical entity. As part of the preclinical investigations, which
of the following battery of toxicity tests cannot be waived and MUST be completed? - correct
answers Genotoxicity
A company is developing a new line of products in an area that is new to the company. What is
the BEST approach? - correct answers Summarize regulatory documents and history and provide
the information to the management team.
A company is developing an (unapproved) drug-device combination product but is not sure to
which center it should submit its marketing application. The company should first submit: -
correct answers A Request for Designation to the Office of Combination Products.
A company is developing an unapproved cell and gene therapy that is a combination product
(device-biologic). What application type and to which center should the company submit its
application for marketing approval? - correct answers Submit a Biologic License Application to
CBER.
A company is developing an unapproved drug-device combination product in which the primary
mode of action is the drug. What application type and to which center should the company
submit its application for marketing approval? - correct answers Submit a New Drug Application
to CDER.
A detailed summary of product quality (CTD Module 2.3 Quality Overall Summary) and a
declaration statement (CTD Module 1.4.1 Quality) are required as part of a Marketing
Authorisation Application in the EU. Who has responsibility for signing this declaration
statement? - correct answers Expert with the necessary technical or professional qualifications.
A drug that has currently accepted medical use, and has limited potential for abuse, physical or
psychological dependence, would likely be placed in which controlled substance schedule? -
correct answers Schedule IV
CORRECT QUESTIONS AND ANSWERS
2025/2026
- correct answers
A biotechnology company is developing a follow-on biologic it claims is similar to an authorised
biologic medicinal product and already available on the market. What should the regulatory
professional submit with the Marketing Authorisation Application dossier? - correct answers Full
quality dossier supplemented by the demonstration of comparability.
A clinical investigator would like to use an investigational medicinal product to treat a gravely ill
patient who does not meet the protocol inclusion criteria. However, in the expert opinion of the
clinical investigator, the product would be the best option for that patient. What action is MOST
appropriate for the clinical investigator to take? - correct answers Obtain approval from the CA
for compassionate use of the product for this particular patient.
A clinical trial for a medicinal product was conducted in several European countries and has
been finalized. What is the MOST appropriate next regulatory step? - correct answers File a
declaration on the end of the clinical trial to the CA and ethics committees of the participating
countries.
A company has a product on the market in Country X. To ensure successful launch of the
product in Country Y, which of the following resources should be examined FIRST? - correct
answers Country Y's regulatory agency website.
, A company is developing a new chemical entity. As part of the preclinical investigations, which
of the following battery of toxicity tests cannot be waived and MUST be completed? - correct
answers Genotoxicity
A company is developing a new line of products in an area that is new to the company. What is
the BEST approach? - correct answers Summarize regulatory documents and history and provide
the information to the management team.
A company is developing an (unapproved) drug-device combination product but is not sure to
which center it should submit its marketing application. The company should first submit: -
correct answers A Request for Designation to the Office of Combination Products.
A company is developing an unapproved cell and gene therapy that is a combination product
(device-biologic). What application type and to which center should the company submit its
application for marketing approval? - correct answers Submit a Biologic License Application to
CBER.
A company is developing an unapproved drug-device combination product in which the primary
mode of action is the drug. What application type and to which center should the company
submit its application for marketing approval? - correct answers Submit a New Drug Application
to CDER.
A detailed summary of product quality (CTD Module 2.3 Quality Overall Summary) and a
declaration statement (CTD Module 1.4.1 Quality) are required as part of a Marketing
Authorisation Application in the EU. Who has responsibility for signing this declaration
statement? - correct answers Expert with the necessary technical or professional qualifications.
A drug that has currently accepted medical use, and has limited potential for abuse, physical or
psychological dependence, would likely be placed in which controlled substance schedule? -
correct answers Schedule IV
