Introduction: Technology transfer in pharmaceuticals requires compliance with approved regulatory bodies and agencies to ensure safe, effective, and lawful movement of knowledge, processes, materials, and intellectual property. B. Pharm students must understand roles of authorities such as CDSCO, DCGI, FDA, EMA, ICH, WIPO, and institutional bodies (TTOs, IBCs, IECs) plus standards like GMP, GLP, GCP, DMF and MTAs. Key concepts include licensing, patents, regulatory dossiers, biosafety, validation, comparability, and documentation during scale-up and site transfer. Mastery of these terms and agencies helps students navigate compliance, protect IP, and plan regulatory submissions. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which Indian agency is primarily responsible for approving clinical trials and new drugs in India?
- Food Safety and Standards Authority of India
- Central Drugs Standard Control Organization
- National Pharmaceutical Pricing Authority
- Indian Council of Medical Research
Correct Answer: Central Drugs Standard Control Organization
Q2. The head of CDSCO who oversees drug approvals in India is commonly referred to as:
- Drug Controller General of India
- Chief Medical Officer
- National Drug Supervisor
- Pharmaceutical Commissioner
Correct Answer: Drug Controller General of India
Q3. Which international organization focuses on harmonizing technical requirements for pharmaceuticals among major regions?
- World Health Organization (WHO)
- International Council for Harmonisation (ICH)
- World Intellectual Property Organization (WIPO)
- Food and Agriculture Organization (FAO)
Correct Answer: International Council for Harmonisation (ICH)
Q4. Which regulatory pathway is specific to abbreviated approvals for generic drugs in the USA?
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Biologics License Application (BLA)
- Investigational New Drug (IND)
Correct Answer: Abbreviated New Drug Application (ANDA)
Q5. In technology transfer, the formal agreement that governs transfer of tangible biological materials between institutions is called:
- Confidentiality Agreement
- Material Transfer Agreement
- License Agreement
- Collaboration Agreement
Correct Answer: Material Transfer Agreement
Q6. Which agency manages patent cooperation and international intellectual property frameworks?
- World Health Organization
- World Intellectual Property Organization
- International Monetary Fund
- Organisation for Economic Co-operation and Development
Correct Answer: World Intellectual Property Organization
Q7. Good Manufacturing Practice (GMP) is primarily inspected to ensure what aspect of technology transfer?
- Safety of laboratory animals
- Quality and consistency of manufactured products
- Academic publication standards
- Marketing authorization fees
Correct Answer: Quality and consistency of manufactured products
Q8. Which document submitted to regulators describes manufacturing processes, quality controls, and stability data for a pharmaceutical product?
- Clinical trial protocol
- Common Technical Document (CTD)
- Material Safety Data Sheet
- Institutional Review Board minutes
Correct Answer: Common Technical Document (CTD)
Q9. Institutional bodies that review ethical aspects of clinical research and protect participant rights are called:
- Technology Transfer Offices
- Institutional Ethics Committees
- Central Drug Licenses
- Quality Assurance Units
Correct Answer: Institutional Ethics Committees
Q10. Which Indian committee is most relevant for oversight of animal experiments used during technology transfer and preclinical studies?
- Institutional Biosafety Committee
- Central Drugs Standard Control Organization
- Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)
- Drug Controller General of India
Correct Answer: Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)
Q11. A Technology Transfer Office (TTO) within a university typically handles which of the following?
- Clinical trial monitoring
- Management of intellectual property and licensing
- Manufacturing site inspections
- Drug pricing negotiations
Correct Answer: Management of intellectual property and licensing
Q12. The Bayh-Dole Act in the United States impacts technology transfer by:
- Prohibiting universities from filing patents
- Allowing institutions to retain title to inventions from federally funded research
- Centralizing all patents under the NIH
- Restricting licensing of government-funded inventions
Correct Answer: Allowing institutions to retain title to inventions from federally funded research
Q13. During a site transfer of manufacturing, regulators expect documented evidence of:
- Marketing strategies
- Product comparability and validation between sites
- Investor agreements
- Patent prosecution strategy
Correct Answer: Product comparability and validation between sites
Q14. Which regulatory submission contains detailed quality information for an excipient or drug component provided by a supplier?
- Clinical Study Report
- Drug Master File (DMF)
- Patent Application
- Material Transfer Agreement
Correct Answer: Drug Master File (DMF)
Q15. Compliance with Good Laboratory Practice (GLP) is most relevant to which stage of technology transfer?
- Marketing authorization
- Analytical method development and preclinical safety studies
- Patent filing procedures
- Commercial sales
Correct Answer: Analytical method development and preclinical safety studies
Q16. Which international agreement sets minimum standards for intellectual property protection affecting tech transfer globally?
- TRIPS Agreement
- Helsinki Declaration
- Cures Act
- Orphan Drug Regulation
Correct Answer: TRIPS Agreement
Q17. A key deliverable in a technology transfer plan that demonstrates a process produces consistent product quality is called:
- Stability protocol
- Process validation report
- Patent certificate
- Ethics approval letter
Correct Answer: Process validation report
Q18. Which regulatory body is responsible for food and drug oversight in the United States?
- European Medicines Agency
- Food and Drug Administration
- Central Drugs Standard Control Organization
- National Institutes of Health
Correct Answer: Food and Drug Administration
Q19. In the context of technology transfer, a confidentiality agreement is primarily used to:
- Authorize clinical trials
- Protect proprietary information during negotiations
- Register a clinical trial in a public database
- Document batch release testing
Correct Answer: Protect proprietary information during negotiations
Q20. Which guideline addresses safety and ethical principles for clinical trials internationally?
- ICH-GCP (Good Clinical Practice)
- ISO 9001
- GLP Guidelines
- GMP Annexes
Correct Answer: ICH-GCP (Good Clinical Practice)
Q21. For regulatory submissions, stability studies are commonly designed according to which guideline?
- ICH Q1A
- ICH Q3A
- GMP Schedule M
- TRIPS Article 27
Correct Answer: ICH Q1A
Q22. Which organization accredits testing and calibration laboratories to ensure competence for analytical work in tech transfer?
- World Health Organization
- National Accreditation Board for Testing and Calibration Laboratories (NABL)
- Food and Drug Administration
- World Intellectual Property Organization
Correct Answer: National Accreditation Board for Testing and Calibration Laboratories (NABL)
Q23. When transferring an analytical method, which document demonstrates the method performs equivalently at the receiving site?
- Method validation/transfer report
- Patent application
- Material Transfer Agreement
- Marketing authorization
Correct Answer: Method validation/transfer report
Q24. Which Indian agency governs biomedical research ethics and issues national guidelines relevant to clinical research?
- Central Drugs Standard Control Organization
- Indian Council of Medical Research
- Department of Biotechnology
- National Health Mission
Correct Answer: Indian Council of Medical Research
Q25. In technology transfer, data exclusivity provides which type of protection?
- Prevents any patents on the molecule
- Protects regulator-submitted clinical data from use by competitors for a period
- Guarantees marketing approval in all countries
- Eliminates need for GMP compliance
Correct Answer: Protects regulator-submitted clinical data from use by competitors for a period
Q26. Which regulatory filing is required in many countries before initiating human clinical trials?
- Biologics License Application
- Investigational New Drug application or equivalent
- Abbreviated New Drug Application
- Marketing Authorization Renewal
Correct Answer: Investigational New Drug application or equivalent
Q27. Technology transfer for biosafety-level organisms typically requires approval from:
- Institutional Biosafety Committee and relevant national biosafety authority
- Patent office only
- Local pharmacy council
- Food Safety and Standards Authority
Correct Answer: Institutional Biosafety Committee and relevant national biosafety authority
Q28. The primary role of a Drug Master File (DMF) in tech transfer is to:
- Provide confidential detailed manufacturing information to regulators without disclosing to the applicant
- Serve as a marketing brochure
- Replace clinical trial reports
- Grant patent rights
Correct Answer: Provide confidential detailed manufacturing information to regulators without disclosing to the applicant
Q29. Which regulatory concept assesses whether a product made at a new site is comparable to the reference product?
- Bioequivalence and comparability assessment
- Patentability search
- Market exclusivity review
- Ethics committee approval
Correct Answer: Bioequivalence and comparability assessment
Q30. During commercialization, post-marketing safety monitoring of adverse events is known as:
- Quality control testing
- Pharmacovigilance
- Method validation
- Material transfer
Correct Answer: Pharmacovigilance
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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