RAC-Drugs Exam (Summer
2026) Questions and Answers
2026/2027 |Already Graded A+|
Verified and Updated
CTD Module 1 - CORRECT ANSWER -Region specific administrative data
CTD Module 2 - CORRECT ANSWER -Quality Overall Summary
CTD Module 3 - CORRECT ANSWER -quality/CMC; Drug Substance and Drug
Product Information
CTD Module 4 - CORRECT ANSWER -Nonclinical Study Reports
CTD Module 5 - CORRECT ANSWER -clinical study reports
,Committee for Medicinal Products for Human Use (CHMP) - CORRECT ANSWER -
EMA's scientific committee responsible for human medicines and prepares
scientific opinions on whether the medicine may be authorized after thorough
evaluation of the MAA.
ALCOA+ - CORRECT ANSWER -Attributable
Legible
Contemporaneous
Original
Accurate
Complete
Consistent
Enduring
Available
ICH S7A - CORRECT ANSWER -Guidance for safety pharmacology studies for
human pharmaceuticals. All human pharmaceuticals should be reasonably safe for
humans
ICH E14/S7B - CORRECT ANSWER -outlines acceptance of in vitro hERG (human
ether-a-go-go related gene) and an in vivo QT interval study data
, hERG assay - CORRECT ANSWER -
India's Central Drugs Standard Control Organization (CDSCO) - CORRECT ANSWER -
to safeguard and enhance the public health by assuring the safety, efficcy, and
quality of drugs, cosmetics, and medical devices
Therapeutic Goods Administration (TGA) - CORRECT ANSWER -safeguards and
enhanced the health of the Australian community through effective and timely
regulation of therapeutic goods
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) - CORRECT ANSWER
-protects the public health by assuring the safety, efficacy, and quality of
pharmaceuticals and medical devices
National Medical Products Administration (NMPA) - CORRECT ANSWER -to
supervise the safety of drugs (including traditional Chinese medicines [TCMs] and
ethno-medicines), medical devices, and cosmetics
2026) Questions and Answers
2026/2027 |Already Graded A+|
Verified and Updated
CTD Module 1 - CORRECT ANSWER -Region specific administrative data
CTD Module 2 - CORRECT ANSWER -Quality Overall Summary
CTD Module 3 - CORRECT ANSWER -quality/CMC; Drug Substance and Drug
Product Information
CTD Module 4 - CORRECT ANSWER -Nonclinical Study Reports
CTD Module 5 - CORRECT ANSWER -clinical study reports
,Committee for Medicinal Products for Human Use (CHMP) - CORRECT ANSWER -
EMA's scientific committee responsible for human medicines and prepares
scientific opinions on whether the medicine may be authorized after thorough
evaluation of the MAA.
ALCOA+ - CORRECT ANSWER -Attributable
Legible
Contemporaneous
Original
Accurate
Complete
Consistent
Enduring
Available
ICH S7A - CORRECT ANSWER -Guidance for safety pharmacology studies for
human pharmaceuticals. All human pharmaceuticals should be reasonably safe for
humans
ICH E14/S7B - CORRECT ANSWER -outlines acceptance of in vitro hERG (human
ether-a-go-go related gene) and an in vivo QT interval study data
, hERG assay - CORRECT ANSWER -
India's Central Drugs Standard Control Organization (CDSCO) - CORRECT ANSWER -
to safeguard and enhance the public health by assuring the safety, efficcy, and
quality of drugs, cosmetics, and medical devices
Therapeutic Goods Administration (TGA) - CORRECT ANSWER -safeguards and
enhanced the health of the Australian community through effective and timely
regulation of therapeutic goods
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) - CORRECT ANSWER
-protects the public health by assuring the safety, efficacy, and quality of
pharmaceuticals and medical devices
National Medical Products Administration (NMPA) - CORRECT ANSWER -to
supervise the safety of drugs (including traditional Chinese medicines [TCMs] and
ethno-medicines), medical devices, and cosmetics
