RAC DRUGS TEST BANK UPDATED
COMPLETE QUESTIONS WITH ACCURATE
ANSWERS
●● Office of Regulatory Affairs (ORA)
Answer: Inspects and reviews products offered for entry into US.
Implement policies and outreaches for product portfolios.
●● Office of Global Policy & Strategy (OGPS)
Answer: serves as a pan-agency coordinator, information distributor, and
access point for multilateral organizations. Addresses international trade
of regulated products and mutual recognition agreements, facilitates
information with global counterparts, and manages FDA's foreign
offices.
●● Office of International Products (OIP)
Answer: coordinates the FDA's international work to help foster
partnerships with counterpart foreign agencies and international orgs.
Offices focus on specific regions: Latin America (Costa Rica); Europe
(Brussels, London); China (Beijing), and India (New Delhi).
●● Confidentiality Commitment
,Answer: sets up legal framework for FDA to share certain kinds of non-
public info with international orgs and regulators in other countries as
part of cooperative law enforcement or regulatory activities.
●● Cooperative Arrangements
Answer: written document that describes the good-faith intentions of the
FDA, other regulators, and international orgs to engage in cooperative
activities.
●● International Committee for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH)
Answer: develops guidelines based on scientific discussions among
regulatory authorities and the pharmaceutical industry. guidelines are
updated continuously. Mission is to achieve greater harmonization
worldwide and ensure that safe, effective, and high-quality medicines
are developed, registered, and maintained in the most resource-efficient
manner while meeting high standards.
●● Office of Global Affairs (OGA)
Answer: Provides leadership and expertise in global health diplomacy to
contribute to a safer, healthier world.
●● European Medicines Agency (EMA)
Answer: Protects and promotes human and animal health by evaluating
and monitoring medicines with the EU.
, ●● Centralised Procedure
Answer: EMA gives opinion, resulting in single marketing authorization
(MA) for whole of EU.
●● National Procedure
Answer: individual member states authorize medicines for use in their
territory.
●● International Council for Harmonisation (ICH)
Answer: promote public health; contribute to the development,
manufacturing, and supervision of new medicines, and develop technical
guidelines that can be implemented by regulatory bodies
●● Medical Dictionary for Regulatory Activities (MedDRA)
Answer: highly specific, standardized medical terminology used to
facilitate sharing of regulatory info used for registration, documentation,
and safety monitoring of medical products before and after marketing
authorization
●● Medicinal Product Development Continuum
Answer: 1. Discovery & development
2. Pre-clinical research
3. Clinical research
COMPLETE QUESTIONS WITH ACCURATE
ANSWERS
●● Office of Regulatory Affairs (ORA)
Answer: Inspects and reviews products offered for entry into US.
Implement policies and outreaches for product portfolios.
●● Office of Global Policy & Strategy (OGPS)
Answer: serves as a pan-agency coordinator, information distributor, and
access point for multilateral organizations. Addresses international trade
of regulated products and mutual recognition agreements, facilitates
information with global counterparts, and manages FDA's foreign
offices.
●● Office of International Products (OIP)
Answer: coordinates the FDA's international work to help foster
partnerships with counterpart foreign agencies and international orgs.
Offices focus on specific regions: Latin America (Costa Rica); Europe
(Brussels, London); China (Beijing), and India (New Delhi).
●● Confidentiality Commitment
,Answer: sets up legal framework for FDA to share certain kinds of non-
public info with international orgs and regulators in other countries as
part of cooperative law enforcement or regulatory activities.
●● Cooperative Arrangements
Answer: written document that describes the good-faith intentions of the
FDA, other regulators, and international orgs to engage in cooperative
activities.
●● International Committee for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH)
Answer: develops guidelines based on scientific discussions among
regulatory authorities and the pharmaceutical industry. guidelines are
updated continuously. Mission is to achieve greater harmonization
worldwide and ensure that safe, effective, and high-quality medicines
are developed, registered, and maintained in the most resource-efficient
manner while meeting high standards.
●● Office of Global Affairs (OGA)
Answer: Provides leadership and expertise in global health diplomacy to
contribute to a safer, healthier world.
●● European Medicines Agency (EMA)
Answer: Protects and promotes human and animal health by evaluating
and monitoring medicines with the EU.
, ●● Centralised Procedure
Answer: EMA gives opinion, resulting in single marketing authorization
(MA) for whole of EU.
●● National Procedure
Answer: individual member states authorize medicines for use in their
territory.
●● International Council for Harmonisation (ICH)
Answer: promote public health; contribute to the development,
manufacturing, and supervision of new medicines, and develop technical
guidelines that can be implemented by regulatory bodies
●● Medical Dictionary for Regulatory Activities (MedDRA)
Answer: highly specific, standardized medical terminology used to
facilitate sharing of regulatory info used for registration, documentation,
and safety monitoring of medical products before and after marketing
authorization
●● Medicinal Product Development Continuum
Answer: 1. Discovery & development
2. Pre-clinical research
3. Clinical research
