Regulatory requirements of TGA and ROW MCQs With Answer

Regulatory requirements of TGA and ROW MCQs With Answer helps M. Pharm students strengthen their command of Australia’s Therapeutic Goods Administration (TGA) framework and key “Rest of World” (ROW) regulatory expectations. This quiz explores ARTG inclusion pathways, medicine and device classifications, clinical trial schemes (CTN/CTX), pharmacovigilance, labelling orders, special pathways (orphan, priority, provisional), and evidence standards. It also covers ROW essentials such as CPP, ACTD, reliance mechanisms, and stability for climatic zones. Designed for exam readiness and practical understanding, these MCQs go beyond definitions to test application, critical distinctions, and real-world compliance details. Work through them to validate your regulatory reasoning, identify knowledge gaps, and gain confidence for both academic assessments and future professional roles in Regulatory Affairs.

Q1. In Australia, before a therapeutic product can be supplied, which statement best describes ARTG inclusion requirements?

• All therapeutic goods must be included in the ARTG unless specifically exempt or excluded
• Only prescription medicines must be included in the ARTG
• Only imported products must be included in the ARTG
• Only medical devices Class II and above require ARTG inclusion

Correct Answer: All therapeutic goods must be included in the ARTG unless specifically exempt or excluded

Q2. What does “AUST L” on a medicine label signify in the TGA framework?

• Listed medicines (lower risk) included based on sponsor self-certification of quality and safety and permitted indications; no pre‑market efficacy evaluation
• Medicines with full pre‑market efficacy evaluation by TGA
• Prescription-only registered medicines
• Export-only medicines with no Australian GMP requirements

Correct Answer: Listed medicines (lower risk) included based on sponsor self-certification of quality and safety and permitted indications; no pre‑market efficacy evaluation

Q3. Assessed Listed Medicines (AUST L(A)) are best described as:

• Listed complementary medicines with TGA-assessed efficacy for specific indications
• Prescription medicines evaluated for safety, quality, and efficacy
• Export-only products not permitted on the Australian market
• Unscheduled products not subject to the Therapeutic Goods Act

Correct Answer: Listed complementary medicines with TGA-assessed efficacy for specific indications

Q4. Which are the two TGA clinical trial schemes for investigational products in Australia?

• IND and IDE
• CTN and CTX
• MAA and NDA
• CTA and CTC

Correct Answer: CTN and CTX

Q5. Which statement about medical device classification in Australia is correct?

• Australia uses a risk-based classification aligned with EU classes (I, Is/Im, IIa, IIb, III, AIMD)
• Australia uses only two device classes: low and high risk
• All devices require TGA in-house bench testing prior to ARTG inclusion
• In vitro diagnostic devices (IVDs) are not regulated by the TGA

Correct Answer: Australia uses a risk-based classification aligned with EU classes (I, Is/Im, IIa, IIb, III, AIMD)

Q6. For inclusion of a Class IIb medical device in the ARTG, which evidence pathway can be acceptable (subject to TGA policies and any transition rules)?

• A CE certificate issued by an EU Notified Body, used as evidence of conformity assessment and accepted by TGA
• A US FDA 510(k) clearance automatically guarantees ARTG inclusion
• Self-declaration only, with no third-party evidence required
• Approval by any foreign regulator always substitutes for TGA requirements

Correct Answer: A CE certificate issued by an EU Notified Body, used as evidence of conformity assessment and accepted by TGA

Q7. Which code governs advertising of therapeutic goods to the public in Australia?

• Therapeutic Goods Advertising Code 2021
• 21 CFR Parts 210/211
• Australian Broadcasting Standards for Health Products
• ICH Q10 Pharmaceutical Quality System

Correct Answer: Therapeutic Goods Advertising Code 2021

Q8. Within what timeline must sponsors report serious adverse reactions (ICSRs) to the TGA?

• 7 calendar days
• 10 business days
• 15 calendar days
• 30 calendar days

Correct Answer: 15 calendar days

Q9. For pharmacovigilance in Australia, sponsors must have which of the following?

• An Australian pharmacovigilance contact person who is responsible and contactable 24/7
• Only an EU-based QPPV with no Australian contact
• A US-based safety officer to handle global cases only
• Company CEO sign-off for every adverse event

Correct Answer: An Australian pharmacovigilance contact person who is responsible and contactable 24/7

Q10. The principal national database of approved therapeutic goods in Australia is:

• Australian Register of Therapeutic Goods (ARTG)
• EudraGMDP
• Orange Book
• DailyMed

Correct Answer: Australian Register of Therapeutic Goods (ARTG)

Q11. Which Therapeutic Goods Order (TGO) specifies labelling requirements for non-prescription medicines?

• TGO 91
• TGO 92
• TGO 77
• TGO 101

Correct Answer: TGO 92

Q12. For orphan drug designation in Australia, the prevalence threshold is:

• Less than 1 in 10,000 people
• Less than 3 in 10,000 people
• Less than 5 in 10,000 people
• Less than 10 in 10,000 people

Correct Answer: Less than 5 in 10,000 people

Q13. Under TGA’s Priority Review pathway for certain prescription medicines, the target evaluation timeframe is:

• 90 calendar days
• 150 working days
• 210 working days
• 12 months

Correct Answer: 150 working days

Q14. The initial period of TGA Provisional Approval (provisional registration) is generally:

• 6 months
• 1 year
• 2 years
• 5 years

Correct Answer: 2 years

Q15. Which is true for “Export Only” medicines in Australia?

• They must be included in the ARTG in a dedicated Export Only entry and bear “For export only” labelling
• They do not require ARTG inclusion if not sold domestically
• They must be approved by the US FDA before export
• They cannot be manufactured in Australia

Correct Answer: They must be included in the ARTG in a dedicated Export Only entry and bear “For export only” labelling

Q16. In many ROW markets, which document is often required under the WHO Certification Scheme to support registration?

• Certificate of Pharmaceutical Product (CPP)
• Certificate of Suitability (CEP)
• Certificate of Analysis (CoA)
• Drug Master File (DMF)

Correct Answer: Certificate of Pharmaceutical Product (CPP)

Q17. What is the ICH/WHO recommended long-term stability condition for products targeting Climatic Zone IVb (common in many ROW countries)?

• 25°C/60% RH
• 30°C/65% RH
• 30°C/75% RH
• 40°C/75% RH

Correct Answer: 30°C/75% RH

Q18. Which dossier format is widely used in several non-ICH markets influenced by ASEAN guidelines?

• eCTD
• ACTD
• Orange Book
• EU Risk Management Plan

Correct Answer: ACTD

Q19. What is the data exclusivity period for new chemical entities in Australia?

• 3 years
• 5 years
• 8 years
• 12 years

Correct Answer: 5 years

Q20. In the context of ROW approvals, what best characterizes a “reliance” regulatory pathway?

• A national authority uses another reference regulator’s assessment reports to inform and expedite its own decision
• Automatic approval in one country when another approves
• Acceptance of only US FDA decisions without further review
• Use of WHO prequalification only for vaccines

Correct Answer: A national authority uses another reference regulator’s assessment reports to inform and expedite its own decision

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