RAC-DRUGS EXAM QUESTIONS AND CORRECT
DETAILED ANSWERS – LATEST UPDATE THIS YEAR
JUST RELEASED.
Food & Drug Administration (FDA) - ..(answers)..Agency of Dept. of Health &
Human Services (HHS). Protects public health by assuring safety, efficacy, and
security of human drugs and biological products. Inspects imported goods. Works
with foreign bodies and external agencies to ensure medicinal products are safe
and secure for human use.
Office of Regulatory Affairs (ORA) - ..(answers)..Inspects and reviews products
offered for entry into US. Implement policies and outreaches for product
portfolios.
Office of Global Policy & Strategy (OGPS) - ..(answers)..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) - ..(answers)..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 - ..(answers)..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 - ..(answers)..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) - ..(answers)..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) - ..(answers)..Provides leadership and expertise in
global health diplomacy to contribute to a safer, healthier world.
European Medicines Agency (EMA) - ..(answers)..Protects and promotes human
and animal health by evaluating and monitoring medicines with the EU.
Centralised Procedure - ..(answers)..EMA gives opinion, resulting in single
marketing authorization (MA) for whole of EU.
National Procedure - ..(answers)..individual member states authorize medicines
for use in their territory.
DETAILED ANSWERS – LATEST UPDATE THIS YEAR
JUST RELEASED.
Food & Drug Administration (FDA) - ..(answers)..Agency of Dept. of Health &
Human Services (HHS). Protects public health by assuring safety, efficacy, and
security of human drugs and biological products. Inspects imported goods. Works
with foreign bodies and external agencies to ensure medicinal products are safe
and secure for human use.
Office of Regulatory Affairs (ORA) - ..(answers)..Inspects and reviews products
offered for entry into US. Implement policies and outreaches for product
portfolios.
Office of Global Policy & Strategy (OGPS) - ..(answers)..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) - ..(answers)..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 - ..(answers)..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 - ..(answers)..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) - ..(answers)..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) - ..(answers)..Provides leadership and expertise in
global health diplomacy to contribute to a safer, healthier world.
European Medicines Agency (EMA) - ..(answers)..Protects and promotes human
and animal health by evaluating and monitoring medicines with the EU.
Centralised Procedure - ..(answers)..EMA gives opinion, resulting in single
marketing authorization (MA) for whole of EU.
National Procedure - ..(answers)..individual member states authorize medicines
for use in their territory.
