RAC-DRUGS EXAM WITH VERIFIED
SOLUTIONS
Food k& kDrug kAdministration k(FDA) k- kcorrect kanswers k-Agency kof kDept. kof kHealth
k& kHuman kServices k(HHS). kProtects kpublic khealth kby kassuring ksafety, kefficacy,
kand ksecurity kof khuman kdrugs kand kbiological kproducts. kInspects kimported kgoods.
kWorks kwith kforeign kbodies kand kexternal kagencies kto kensure kmedicinal kproducts
kare ksafe kand ksecure kfor khuman kuse.
Office kof kRegulatory kAffairs k(ORA) k- kcorrect kanswers k-Inspects kand kreviews
kproducts koffered kfor kentry kinto kUS. kImplement kpolicies kand koutreaches kfor
kproduct kportfolios.
Office kof kGlobal kPolicy k& kStrategy k(OGPS) k- kcorrect kanswers k-serves kas ka kpan-
agency kcoordinator, kinformation kdistributor, kand kaccess kpoint kfor kmultilateral
korganizations. kAddresses kinternational ktrade kof kregulated kproducts kand kmutual
krecognition kagreements, kfacilitates kinformation kwith kglobal kcounterparts, kand
kmanages kFDA's kforeign koffices.
, Office kof kInternational kProducts k(OIP) k- kcorrect kanswers k-coordinates kthe kFDA's
kinternational kwork kto khelp kfoster kpartnerships kwith kcounterpart kforeign kagencies
kand kinternational korgs. kOffices kfocus kon kspecific kregions: kLatin kAmerica k(Costa
kRica); kEurope k(Brussels, kLondon); kChina k(Beijing), kand kIndia k(New kDelhi).
Confidentiality kCommitment k- kcorrect kanswers k-sets kup klegal kframework kfor kFDA
kto kshare kcertain kkinds kof knon-public kinfo kwith kinternational korgs kand kregulators
kin kother kcountries kas kpart kof kcooperative klaw kenforcement kor kregulatory
kactivities.
Cooperative kArrangements k- kcorrect kanswers k-written kdocument kthat kdescribes
kthe kgood-faith kintentions kof kthe kFDA, kother kregulators, kand kinternational korgs kto
kengage kin kcooperative kactivities.
International kCommittee kfor kHarmonisation kof kTechnical kRequirements kfor
kPharmaceuticals kfor kHuman kUse k(ICH) k- kcorrect kanswers k-develops kguidelines
kbased kon kscientific kdiscussions kamong kregulatory kauthorities kand kthe
kpharmaceutical kindustry. kguidelines kare kupdated kcontinuously. kMission kis kto
kachieve kgreater kharmonization kworldwide kand kensure kthat ksafe, keffective, kand
khigh-quality kmedicines kare kdeveloped, kregistered, kand kmaintained kin kthe kmost
kresource-efficient kmanner kwhile kmeeting khigh kstandards.
Office kof kGlobal kAffairs k(OGA) k- kcorrect kanswers k-Provides kleadership kand
kexpertise kin kglobal khealth kdiplomacy kto kcontribute kto ka ksafer, khealthier kworld.
European kMedicines kAgency k(EMA) k- kcorrect kanswers k-Protects kand kpromotes
khuman kand kanimal khealth kby kevaluating kand kmonitoring kmedicines kwith kthe kEU.
Centralised kProcedure k- kcorrect kanswers k-EMA kgives kopinion, kresulting kin ksingle
kmarketing kauthorization k(MA) kfor kwhole kof kEU.
National kProcedure k- kcorrect kanswers k-individual kmember kstates kauthorize
kmedicines kfor kuse kin ktheir kterritory.
International kCouncil kfor kHarmonisation k(ICH) k- kcorrect kanswers k-promote kpublic
khealth; kcontribute kto kthe kdevelopment, kmanufacturing, kand ksupervision kof knew
kmedicines, kand kdevelop ktechnical kguidelines kthat kcan kbe kimplemented kby
kregulatory kbodies
Medical kDictionary kfor kRegulatory kActivities k(MedDRA) k- kcorrect kanswers k-highly
kspecific, kstandardized kmedical kterminology kused kto kfacilitate ksharing kof kregulatory
kinfo kused kfor kregistration, kdocumentation, kand ksafety kmonitoring kof kmedical
kproducts kbefore kand kafter kmarketing kauthorization
SOLUTIONS
Food k& kDrug kAdministration k(FDA) k- kcorrect kanswers k-Agency kof kDept. kof kHealth
k& kHuman kServices k(HHS). kProtects kpublic khealth kby kassuring ksafety, kefficacy,
kand ksecurity kof khuman kdrugs kand kbiological kproducts. kInspects kimported kgoods.
kWorks kwith kforeign kbodies kand kexternal kagencies kto kensure kmedicinal kproducts
kare ksafe kand ksecure kfor khuman kuse.
Office kof kRegulatory kAffairs k(ORA) k- kcorrect kanswers k-Inspects kand kreviews
kproducts koffered kfor kentry kinto kUS. kImplement kpolicies kand koutreaches kfor
kproduct kportfolios.
Office kof kGlobal kPolicy k& kStrategy k(OGPS) k- kcorrect kanswers k-serves kas ka kpan-
agency kcoordinator, kinformation kdistributor, kand kaccess kpoint kfor kmultilateral
korganizations. kAddresses kinternational ktrade kof kregulated kproducts kand kmutual
krecognition kagreements, kfacilitates kinformation kwith kglobal kcounterparts, kand
kmanages kFDA's kforeign koffices.
, Office kof kInternational kProducts k(OIP) k- kcorrect kanswers k-coordinates kthe kFDA's
kinternational kwork kto khelp kfoster kpartnerships kwith kcounterpart kforeign kagencies
kand kinternational korgs. kOffices kfocus kon kspecific kregions: kLatin kAmerica k(Costa
kRica); kEurope k(Brussels, kLondon); kChina k(Beijing), kand kIndia k(New kDelhi).
Confidentiality kCommitment k- kcorrect kanswers k-sets kup klegal kframework kfor kFDA
kto kshare kcertain kkinds kof knon-public kinfo kwith kinternational korgs kand kregulators
kin kother kcountries kas kpart kof kcooperative klaw kenforcement kor kregulatory
kactivities.
Cooperative kArrangements k- kcorrect kanswers k-written kdocument kthat kdescribes
kthe kgood-faith kintentions kof kthe kFDA, kother kregulators, kand kinternational korgs kto
kengage kin kcooperative kactivities.
International kCommittee kfor kHarmonisation kof kTechnical kRequirements kfor
kPharmaceuticals kfor kHuman kUse k(ICH) k- kcorrect kanswers k-develops kguidelines
kbased kon kscientific kdiscussions kamong kregulatory kauthorities kand kthe
kpharmaceutical kindustry. kguidelines kare kupdated kcontinuously. kMission kis kto
kachieve kgreater kharmonization kworldwide kand kensure kthat ksafe, keffective, kand
khigh-quality kmedicines kare kdeveloped, kregistered, kand kmaintained kin kthe kmost
kresource-efficient kmanner kwhile kmeeting khigh kstandards.
Office kof kGlobal kAffairs k(OGA) k- kcorrect kanswers k-Provides kleadership kand
kexpertise kin kglobal khealth kdiplomacy kto kcontribute kto ka ksafer, khealthier kworld.
European kMedicines kAgency k(EMA) k- kcorrect kanswers k-Protects kand kpromotes
khuman kand kanimal khealth kby kevaluating kand kmonitoring kmedicines kwith kthe kEU.
Centralised kProcedure k- kcorrect kanswers k-EMA kgives kopinion, kresulting kin ksingle
kmarketing kauthorization k(MA) kfor kwhole kof kEU.
National kProcedure k- kcorrect kanswers k-individual kmember kstates kauthorize
kmedicines kfor kuse kin ktheir kterritory.
International kCouncil kfor kHarmonisation k(ICH) k- kcorrect kanswers k-promote kpublic
khealth; kcontribute kto kthe kdevelopment, kmanufacturing, kand ksupervision kof knew
kmedicines, kand kdevelop ktechnical kguidelines kthat kcan kbe kimplemented kby
kregulatory kbodies
Medical kDictionary kfor kRegulatory kActivities k(MedDRA) k- kcorrect kanswers k-highly
kspecific, kstandardized kmedical kterminology kused kto kfacilitate ksharing kof kregulatory
kinfo kused kfor kregistration, kdocumentation, kand ksafety kmonitoring kof kmedical
kproducts kbefore kand kafter kmarketing kauthorization
