RAC-Drugs Exam (Summer 2025)
2025/2026 Exam Questions with 100%
Correct Answers | Latest Update
Food & Drug Administration (FDA) - 🧠ANSWER ✔✔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) - 🧠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
3
COPYRIGHT©JOSHCLAY 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY
STATEMENT. ALL RIGHTS RESERVED
2025/2026 Exam Questions with 100%
Correct Answers | Latest Update
Food & Drug Administration (FDA) - 🧠ANSWER ✔✔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) - 🧠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
3
COPYRIGHT©JOSHCLAY 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY
STATEMENT. ALL RIGHTS RESERVED
